Winter 2013 final

CANADIAN VIGOUR CENTRE

Inside this

issue:

CVC is proud to be a

University of Alberta Centre

Bridging hearts and minds to enhance

cardiovascular care

www.vigour.ualberta.ca

Letter -

PW Armstrong

1

Trial Updates 2-6

Monitoring 6

Biostatistics 7

CVC

Publications and Abstracts

7-8

Winter 2013 Volume 17, No. 3

A foot of fresh snow blankets the ground and the days grow shorter as the winter solstice approaches in northern

Alberta. Now that Canadian - and more recently American - Thanksgiving holidays are in the rear view mirror and

Christmas approaches, it is a fine time to reflect on our many blessings. The origins of Canadian Thanksgiving,

celebrated on the second Monday of October, can be traced to the freezing and stormy sail of Martin Frobisher

who, after finally anchoring in Frobisher Bay off Baffin Island, was prompted by his accompanying minister to be

“thankful to God for their strange and miraculous deliverance in those so dangerous places”. By contrast the first

Thanksgiving in the United States, celebrated on the third Thursday of November, is generally attributed to the

pilgrim feast in Plymouth Massachusetts in 1621 after the first harvest that followed a particularly difficult winter.

Canada and the United States share many things. When John Kennedy addressed the Canadian parliament a few

months after he was elected President of the United States in 1961, he reflected that “Geography has made us

neighbors, history has made us friends, economics has made us partners, necessity has made us allies. What unites

us is far greater than that which divides us.”

Sometimes amidst the challenges associated with achieving our academic mission and pushing the boundaries to

acquire new and clinically relevant knowledge, it is tempting to become dispirited. It is at just those times that it is

crucial to recall that our major limitations are few and largely related to the quality of our ideas, the resourcefulness

and skill with which we develop and communicate them, and the passion and tenacity necessary to realize them.

The spirit of collaboration shared across the longest unpatrolled border in the world separating Canada and the US

is alive and well, as it is with many of our global partners around the world. The sharing of our ideas through

clinical trials, registries and population health outcomes data inform us while at the same time generating a more

lucid path forward. The recruitment of young people to the cause, supporting their training in other academic

centres and countries, as well as the enrichment provided by academic visits to our different institutions is a most

welcome signal of this collaborative spirit. In just the last 60 days, I have had splendid learning experiences and the

great privilege of working with friends and colleagues in Montreal, Quebec, Sydney, Australia, the University of

Leuven in Belgium, Dallas, Texas and Stanford University in California.

Within this issue of the Chronicle, the collaborative spirit and opportunities are reflective of an abundant harvest

and we are thankful to our many partners that enable this. That said, I wish to particularly highlight the outstanding

work of Warren Cantor and his study coordinator Kim Robbins at the Southlake Medical Centre in Ontario and

sincerely thank them for energizing our investigation of a novel anticoagulation system in the Regulate PCI Trial with

great velocity. More details on the trial and their team are featured in this issue of the Chronicle.

As we reflect on our many blessings at this hinge point in the calendar, it is good to recall that “to whom much is

given, much will be required”. From our team at the Canadian VIGOUR Centre to yours, we genuinely extend our

warmest wishes for a Merry Christmas, Happy Hanukkah and enjoyable holiday season. We hope it finds you

amidst the warmth of family and friends, replenishing your energy and spirits and preparing to seize the novel

opportunities afforded by the dawn of the new year ahead.

Letter from Dr. Paul Armstrong:

With kind regards,

Paul W. Armstrong

Page 2 THE CANADIAN CARDIAC CHRONICLE

IMPROVE-IT

As we approach 2014, the year that the IMPROVE

IT trial expects to reach the protocol-defined number of clinical endpoints, the focus becomes

data cleanliness, in addition to patient retention. On the patient retention front, the Participant

Newsletter (Memo #407B) was sent to sites in early September. Please forward your REB

approval letters to CVC. The data cleanliness effort began with Memo #408 (“New Expedited

Queries to be issued”) in late August, and continues with the Data Cleaning Initiative which

began in late October.

We continue to work on answering outstanding

AE QC queries. Remember, if an AE is not an endpoint, then the AE must clearly state this.

Emails have been sent to those sites that either have queries that are still open, or queries that

were answered incorrectly. Your cooperation in addressing these important “AE QC” data queries

within 10 days is appreciated.

Data Cleaning Initiative: a targeted data sweep has

been issued from October 21 - December 13, 2013 with the goal to have all data from study

visits entered into INFORM by the end of 2013. The data sweep will target all late visits, missing

data, and opened/answered critical queries that are more than 10 days late. As always, we appreciate

your assistance, and time, on these initiatives!

Data Clean Up – Commendations to ALL of the

IMPROVE IT CVC sites on achieving >/= 97%!!! As of November 13 20 sites have achieved 100%

monitor clean data, and another 11 sites have achieved 98-99% monitor clean data (this is a

record for the year!!)

As a reminder, an email was sent to all sites in

September regarding the PR Status Reports for study drug. These two reports are to be printed

and filed in your Investigator Site File (in the Drug Accountability Binder). The monitors will be

verifying that these reports are on site and filed accordingly.

CEC Adjudicated Events – please remember to submit any outstanding (de-identified) source

documents to the TIMI CEC.

For further information, please contact Clinical

Trial Project Lead Jodi Parrotta at 1-800-707-9098 (ext. 3) or by email at [email protected].

ODYSSEY OUTCOMES

ODYSSEY Outcomes is one of 12 Phase III trials

that have been initiated as part of the more than 23,000 patient ODYSSEY clinical trial program.

The first Phase III study (ODYSSEY MONO) to report data from the ODYSSEY clinical trial

program showed that it met its primary efficacy endpoint: the mean LDL-C reduction from

baseline to week 24, was significantly greater in patients randomized to alirocumab, as compared

to patients randomized to Ezetimibe (47.2% vs. 15.6%, p<0.0001).

The ODYSSEY Outcomes trial is well underway with over 1400 patients randomized globally. In

Canada, 28 sites have been activated with more than 80 patients screened and 20 randomized.

We are looking forward to activating the remainder of our sites over the coming months

with further increase in screening and recruitment efforts at all sites in Canada.

Don’t forget to complete all your training and regulatory documents while you are waiting on

contracts and ethics! For those sites that have

now screened and/or randomized a patient, don’t

forget to complete your CRF’s and answer any open queries. Please keep an eye out for key trial

updates and Canadian newsletters sent out to your site throughout the trial.

The upcoming Protocol Amendment 2—pending FDA acceptance—is expected soon. We tentatively

plan to submit to Health Canada before end of the year with approval in early 2014. We anticipate

this will help to boost recruitment at participating sites in the coming months. More details will be

forthcoming in the near future.

We’ve had some recent changes to the ODYSSEY

team at CVC and Robert Evans has now transitioned off of the project. We are still

recruiting a few final sites for this study so if you are interested in hearing more about ODYSSEY or

have questions regarding the trial, please contact Clinical Trial Project Lead Amanda Carapellucci at

1-800-707-9098 (ext. 2) or by email at [email protected] or Paula Priest

(ext. 9) or [email protected].

IMProved Reduction of

Outcomes: Vytorin Efficacy International Trial

Sponsored by Merck & Co. Inc., (previously Schering-

Plough Research Institute) this trial is a multicenter,

double-blind, randomized study to establish the

clinical benefit and safety of Vytorin (ezetimibe/

simvastatin Tablet) vs. simvastatin monotherapy in

high-risk patients presenting with acute

coronary syndrome.

ClinicalTrials.gov

Identifier: NCT00202878

Sponsored by Sanofi-

aventis Recherche & Développement this is a

randomized, double-blind, placebo-controlled, parallel

-group study to evaluate the effect of SAR236553/

REGN727 on the occurrence of cardiovascu-

lar events in patients who have recently experienced

an Acute Coronary Syndrome.

ClinicalTrials.gov

Identifier: NCT01663402

Page 3 Volume 17, No. 3

STABILITY

In mid November, GSK released the top-line

results from this study which showed that the study did not meet its primary endpoint of time to

first occurrence of any major adverse cardiovascular event (MACE). This is a rich set of

data which will be closely analyzed in the coming months and we look forward to sharing the full

results in 2014. We appreciate all the hard work from our 32 Canadian sites and all the patients

who contributed to this study over the last five years.

As we clean up and finalize the study files, please make sure to send a copy of your ethics

REGULATE PCI

The REGULATE-PCI held its first North American

Investigator Meeting (IM) in October in Chicago. It was a great opportunity to meet face-to-face

with many of our sites and learn about the protocol and overall study. If you were unable to

attend that meeting, the next North American IM will be occurring in late February 2014 (location

to be determined).

The study is now underway across North America

with over 90 patients enrolled at nine sites. In Canada, Dr. Cantor’s site continues to excel! To

date, they have enrolled 30 patients, and remain the highest global enroller – a title they have held

for nearly two months! Congratulations to Dr. Cantor and his team!! They are a shining

example of what five engaged interventionalists and one keen study coordinator (Kim Robbins)

can accomplish together (see picture inset)!

In November, two more sites were activated in

Canada: Dr. Fung in Vancouver, BC and Dr. Mehta in Hamilton, ON. We look forward to

these two sites enrolling their first patients in the coming weeks.

We will be working hard to get the remainder of

our sites activated in the next couple of months and look forward to having all of our sites

recruiting early in the new year.

For further information, or if you are interested in

participating, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098 (ext. 3) or

by email at [email protected].

PROACT

The Edmonton Emergency Medical Services (EMS)

teams continue to actively recruit patients, with over 180 patients now enrolled into the study.

We appreciate their continued hard work and commitment to this study.

From L to R: Dr Cantor, Dr Miner, Kim, Dr Plante and

Dr Prabhakar (missing Dr Goldman)

STabilisation of

Atherosclerotic plaque By Initiation of darapLadIb

TherapY

Sponsored by Glaxo

SmithKline, this trial is a randomized, placebo-

controlled, double-blind, parallel group, multicenter,

event-driven clinical outcomes study of

darapladib versus placebo in subjects with chronic

coronary heart disease to compare the incidence of

major adverse cardiovascu-lar events.

ClinicalTrials.gov Identifier: NCT00799903

PROACT Providing Rapid Out of

Hospital Acute Cardiovascular Treatment

An Edmonton-region local

initiative sponsored by the University Hospital

Foundation and the Mazankowski Alberta

Heart Institute. Additional support for point of care

meters provided by Alere Inc.

ClinicalTrials.gov

Identifier: NCT01634425

Sponsored by Regado

Biosciences Inc. this is a randomized, open-label,

multi-center, active-controlled, parallel group

study to determine the efficacy and safety of the

REG1 Anticoagulation System Compared to

Bivalirudin in Patients Undergoing Percutaneous

Coronary Intervention

Clinical trials.gov Identifier: NCT01848106

submission and acknowledgement of study closure

letters as well and your FIDS B forms for end of study to us at the Canadian VIGOUR Centre. As

you start to think about archiving your study files, please remember that all study related documents

will need to be archived for 25 years per Health Canada regulations.

If you have any questions or require additional information, please contact Assistant Director,

Clinical Trials, Tracy Temple @ 1-800-707-9098 (ext. 5) or via email at [email protected].

Keep up the great work!

The 2011/2012 phase of the study was presented as a Late Breaking Trial at the Canadian

Cardiovascular Congress in Montreal in October and there was also a Poster Presentation of the

study methods and baseline characteristics - “Providing Rapid Out Of Hospital Acute

Cardiovascular Treatment: PROACT 3”.

For further information please contact Paula Priest

at 1-800-707-9098 (ext. 9) or email at [email protected].

THE CANADIAN CARDIAC CHRONICLE Page 4

AEGIS-I

AEGIS-I is a new Phase 2 study investigating the

safety and tolerability of multiple dose administration of CSL112 in subjects post acute

myocardial infarction. CSL112 is an intravenous apo lipoprotein A-I (apoA-I), purified from human

plasma and reconstituted to form HDL particles. It has shown promise in earlier phase 1 and 2

studies with its ability to rapidly remove cholesterol from atherosclerotic plaque.

We are pleased to be closely collaborating with

the sponsor, CSL, in addition to the Duke Clinical Research Institute, the PERFUSE study group, the

Cleveland Clinic and Quintiles on this study. The Canadian VIGOUR Centre will be

responsible for Project/Site Management and Monitoring for all participating Canadian sites.

Initial invitations have gone out to select Canadian sites who we look forward to working through feasibility and start up with over the next few

months.

For further information, or if you are interested in

hearing more about this study, please contact Assistant Director, Clinical Trials, Tracy Temple at

1-800-707-9098 (ext. 5) or by email at [email protected].

TECOS

After a successful Rejuvenation Meeting in Boston

this November, we are confident that our TECOS sites are feeling revitalized and ready to take on

the final stages of this study! The focus of this meeting was to review the plans and expectations

surrounding the anticipated study end date in the later part of 2014.

The timelines for final patient visits and data lock once the number of adjudicated events has been

met will be tight, so there is a push for sites to enter data not only quickly but meticulously over

the next year, which will help decrease the number of queries generated by data management

and the clinical events committee. Missing data and/or data queries are expected to be cleaned

before reaching the 30 day old mark. Also, please ensure that Principal Investigators are signing SAE

casebooks promptly after the initial data entry is complete.

Congratulations to the following sites with outstanding data items < 30 days!

Dr. Woo & Dixie Hak

Dr. Kaiser & Laura Lee Magennis

Dr. Dumas & Sylvie Gauthier

Dr. Garceau & Lise Mercier

Dr. Yale & Mylene Roy

Dr. Mereu & Bonnie Woloschuk

Dr. Pandey & Sandra Clarus

Dr. Saunders & Lori Richert

Dr. Huynh & Linda Perkins

Dr. Weisnagel & Valerie-Eve Julien

Dr. Sigalas & Darlene Hutton

For any patients that have permanently discontinued study drug or have withdrawn

consent for participation in the study, it is crucial that sites are maintaining the appropriate logs and

worksheets related to these events and are submitting them to CVC on a regular basis. The

Project Team must enter detailed data for each of these patients into a special section of Inform and

we cannot do this without your help!

A friendly reminder to please review your

contracts and submit all current invoices to CVC so that you are reimbursed in a timely manner and

there is not a frantic rush to get these processed during study close-out.

Lyndsey Garritty will be transitioning off the project in December as she prepares for an

upcoming maternity leave. We are currently working on shifting TECOS to Robert Evans, who

some of you may have worked with on the ODYSSEY Outcomes study.

For further information or questions, please contact Clinical Trial Project Lead, Lyndsey

Garritty at 1-800-707-9098 (ext. 4) or via email at [email protected] or Robert Evans

(ext. 1) or [email protected].

Sponsored by Merck & Co.

Inc., TECOS is a Randomized, Placebo

Controlled Clinical Trial to Evaluate Cardiovascular

Outcomes after Treatment with Sitagliptin in Patients

with Type 2 Diabetes Mellitus and Inadequate

Glycemic Control.

ClinicalTrials.gov Identifier: NCT00790205

Sponsored by CSL Behring

LLC, this study is a Phase 2b, multicenter,

randomized, placebo-controlled, dose-ranging

study to investigate the safety and tolerability of

multiple dose administra-tion of CSL112 in subjects

with acute myocardial infarction.

Volume 17, No. 3

SODIUM-HF

Based on the success of the SODIUM-HF pilot,

Phase III of the SODIUM-HF trial aims to evaluate the long-term effects of a low-sodium containing

diet compared to Usual Care in over 1,000 patients with heart failure.

SODIUM-HF is just getting started with an anticipated 15 sites across Canada expected to

participate. Initial invitations have gone out with an overwhelming response to date! Regulatory

documents are being reviewed at several sites and

we plan to activate our first site in early 2014. If

you are a participating site, we look forward to working with you to make this trial a success.

If you are interested in participating in SODIUM-

HF or would like further information, please

contact Clinical Trial Project Lead Melisa Spaling at

780-492-8476 or via email at [email protected]

GUIDE-IT is well under way in Canada with our first two patients enrolled and 4 of our planned 6

sites activated and working hard at screening patients. In North America there are now over

150 patients enrolled with most sites now activat-ed.

Congratulations to Dr. Patricia Campbell, Kim Ronak & Sheilah Heal at the University of Calgary/

Foothills Hospital for enrolling the first two Cana-dian GUIDE-IT patients. Congratulations to our

other active sites:

Dr. Justin Ezekowitz & Quentin

Kushnerik – University of Alberta Hospital/Mazankowksi Alberta Heart Institute,

Edmonton

Dr. Robert McKelvie, Barb Miller & Lydia Morrow – Hamilton Health Sciences,

Hamilton

Dr. Mustafa Toma, Liz Grieve & Cynthia Van Hoof – St. Paul’s Hospital, Vancouver

As screening and enrollment activities heat up, please ensure that you are reviewing your patient

recruitment plans and revising these as needed. CVC and DCRI will be requesting your updated

plans on a regular basis. Screening logs should be sent to CVC every Thursday. These logs are very

helpful and assist the Project Team in identifying enrollment challenges.

Thank you to each of our sites for working hard

on obtaining Protocol Amendment 1 approval so quickly. The inclusion/exclusion revisions in this

amendment should provide for a wider range of

GUIDE-IT

patient eligibility. For those enrolling sites please

ensure that source documents are being sent in and Inform data entered within 5 business days of

each visit. Please refer to the GUIDE-IT website for the most current versions of the eCRF

Instructions, study documents, training items, etc. The website also houses a Frequently Asked

Questions document that is updated continuously.

Monthly GUIDE-IT teleconferences have now

been scheduled for both PI’s and Study Coordinators to attend, which will provide an

excellent venue to gather new screening ideas, understand some of the challenges to enrollment

and possible solutions, and to also ask any questions you may have about the study. Please

check your email or contact CVC for scheduled dates and times.

Thank you to all of our GUIDE-IT sites for your commitment to participate in this important heart

failure study. We are looking forward to working with each of you closely to make this trial a

success!

Lyndsey Garritty will be transitioning off the

project throughout December as she prepares for an upcoming maternity leave. We are pleased to

have Melisa Spaling, assuming the role of Project Lead on this study in the coming weeks. If you

have not already connected with Melisa she will be in touch with all participating sites this month.

For further information, please contact Melisa Spaling, Clinical Trial Project Lead at 780-492-8476 or via email at [email protected]

In collaboration with DCRI

(Duke Clinical Research Institute) and Roche

GUIDE-IT is a prospective, randomized 1:1, multi-

centre clinical trial GUIDing Evidence Based Therapy

Using Biomarker Intensified Treatment in Heart Failure

ClinicalTrials.gov

Identifier: NCT01685840

Funded by the Canadian

Institute of Health Research

(CIHR), SODIUM-HF is a

multicenter, randomized,

open-label Study of Dietary

Intervention Under 100

MMOL in Heart Failure.

SODIUM-HF

Page 5

Page 6 THE CANADIAN CARDIAC CHRONICLE

EXSCEL

The EXSCEL trial is moving right along with over

8300 subjects enrolled globally. Our 24 Canadian sites have been able to contribute 330 subjects,

and that number continues to steadily increase. With the planned expansion and increase in total

enrollment for the EXSCEL trial, your continued support will be critical to the success of the trial!

We would like to congratulate one of our most recently activated sites, Dr. R. Kuritzky and his

staff at Fraser Clinical Trials, who quickly enrolled 13 patients in 4 months. Currently they hold the

top spot for ratio of patients enrolled per month! Additionally we would like to acknowledge our

other top enrolling sites for the months of August 2013 through to October 2013:

Institut Universitaire de Cardiologie et de Pneumologie de Québec, PI – Dr. F. Dubé,

SC – Marilène Bolduc

Surrey Memorial Hospital – Cardiology Clinical Trials, PI – Dr. S. Cheung, SC – Tracy

Cleveland

The Ottawa Hospital, PI – Dr. H. Lochnan, SC – Denise DeCurtis

A big thank you to these sites and to all sites who continue to actively screen and enroll patients -

your efforts and enthusiasm for the EXSCEL trial are greatly appreciated!

As your excellent screening and enrollment work

continues, we will begin to take a closer look at our retention metrics. So far our Canadian sites

have done a fantastic job of retaining patients in the study and we hope to see that trend continue.

Every patient is important – so please ensure you contact the EXSCEL study Hotline to discuss all

cases of patients coming off study drug or potentially withdrawing consent. If you have any

questions or concerns, we encourage you to contact your project lead to discuss them and to

review all the alternative options that are available to your patients.

The Amendment 4 transition is currently 96% complete for Canada. This would not have been

possible without the continued cooperation of each of our sites – thank you to each of you! We

are excited for the upcoming changes from our new sponsor and we look forward to seeing many

of you at the EXSCEL North American Rejuvenation Meeting, scheduled for January 2014!

For further information or if you are interested in participating in this trial, please contact Clinical

Trial Project Lead, Amanda Carapellucci at 1-800-707-9098 (Ext 2) or by email at

[email protected] or Diane Camara at 1-800-725-6585 or by email at

[email protected].

Exenatide Study of

Cardiovascular Event Lowering

Sponsored by Amylin

Pharmaceuticals, Inc. this trial is a pragmatic, long

term, placebo-controlled, double-blinded trial which

seeks to characterize the effects of exenatide once

weekly on cardiovascular(CV) -related outcomes in

patients with type 2 diabetes when added to

the current usual care for glycemic control in a

standard care setting.

ClinicalTrials.gov

Identifier: NCT01144338

MONITORING

In our last issue we highlighted several audit tips

and thought we would continue them into this issue as we feel that sharing these will help us all

to be better prepared for that next audit.

Ensure you have, at minimum, Standard

Operating Procedures (SOPs) on the consent process, AE/SAE documentation and submission

to sponsor/ethics, study drug storage, dispensing and return, screening and eligibility of subjects,

source documentation, and record retention. And don’t forget that every staff member should

be trained on the site SOPs and the training documented.

Consenting of subjects should be done per your

site SOP. The subject should print, sign and date the consent and initial each page (if

applicable. The date of the consent should be in the format that has been approved by the REB.

For example if the REB wants the date to be documented as DD/MM/YYYY, then the date

should be written as 10/09/2013 to note that it is 10th day of September 2013. The study team

member who administers the consent should review that the consent is properly completed

including the format of the date. The consent

process with each patient should be

documented as per your SOP whether you use a consent process checklist or it is hand written

in the progress note. Any consent amendments should be provided to the subject at the next

clinic visit after receiving ethics approval.

Ensure all site staff are listed on the delegation log and that the responsibilities of each staff member are assigned by the principal

investigator (PI) who should sign, initial, and date each entry. While we all know how important

study coordinators (SC) are in running a trial remember they cannot be assigned the following

responsibilities: (1) eligibility of subjects and (2) assessment of AE/SAE’s. The SC can screen

subjects and collect AE/SAE’s. If the delegation log has codes and there are no separate codes

for SC to screen or collect information you can always use “other” or add additional codes

listing what the responsibility is. Finally, any deletion or additions to the log are to be signed/

initialed and dated by the PI not the SC or other site staff.

For monitoring related questions please contact

Lead CRA, Halina Nawrocki at 1-905-896-7292 or by email at [email protected].

Page 7 Volume 17, No. 3

2013 International Year of Statistics: How Statistics Impacts You

While “celebrating” and “statistics” would not

often be found together in a sentence in common conversation, we predict that there has been a

significant increase in its frequency in 2013. This year marks the International Year of Statistics

with its aim of increasing awareness of the impact of statistics across many facets of our lives. Those

of us in clinical research, however, have recognized its invaluable contribution for some

time. This art and science of learning from (or making sense out of) data may seem daunting to

some, but for those of us who have made it our career, we take our role seriously.

Being the bridge between the collected data and answering clinical questions is central to what we

do. Involving those with such expertise, and doing so early on, goes a long way in terms of the

credibility of clinical research. This has been a long-standing commitment at the CVC. Our

biostatistics team is made up of applied methodologists, with backgrounds in

epidemiology, mathematics, measurement, and statistics. We have acquired experience in large

administrative, population-based cohorts and clinical trial databases, and in disease states

including acute coronary syndromes, heart failure, and diabetes. Based on formal training and

experience, we can optimize many aspects of

clinical research, from study design to analysis, and to the interpretation and conclusions of

results. With the other members of the clinical research team, we help to achieve the equilibrium

between statistical and clinical significance.

We also have a unique opportunity to mentor the

next generation of clinical investigators. Conveying an appreciation for statistics is important to the

sustainability and advancement of clinical research. So too is the development and/or application of

novel statistical techniques. At the CVC, we have used a variety of advanced techniques including

multilevel modeling, dynamic risk modeling, gap-time modeling and weighted composite

endpoints to address novel clinical questions.

As 2013 draws to a close, so too does this formal

celebration of statistics. However, as the digital platform (and collection of data) continues to

broaden and pressures increase to conduct more efficient clinical research, the ability to translate

raw data into meaningful information will continue to increase in value. The party must, and will, go

on.

CVC

HOLIDAY

CLOSURE

December 24, 2013

to

January 1, 2014

Should any urgent

issues arise, we

encourage you to call

the designated

helpline for your

study

CVC’s main

voicemail will be

checked daily

throughout the

closure to address

any important

study-related issues.

CVC wishes you and

your families the

happiest of holidays.

Selected CVC Presentations and Publications Since Last Issue

Publications

Armstrong PW, Califf RM. Data and Safety Monitoring Boards: Academic Credit Where Credit Is Due? JAMA 2013; 301:1563-4. http://dx

.doi.org/10.1001/jama.2013.280383

Dianati Maleki N, Stocke K, Zheng Y, Westerhout CM, Fu Y, Chaitman BR, Awad A, Armstrong PW.

An assessment of ST-segment measurement variability between two core electrocardiogram

laboratories. Journal of Electrocardiography In press.

Whellan D, Tricoci P, Chen E, Huang Z, Leibowitz

D, Pascal Vranckx P, Marhefka G, Held C, Nicolau J, Storey RF, Ruzyllo W, Huber K, Sinnaeve P,

Weiss AT, Déry J-P, Moliterno D, Van de Werf F, Aylward P, White, H, Armstrong P, Wallentin L,

Strony J, Harrington RA, Mahaffey KW. Vorapaxar in Acute Coronary Syndrome Patients Undergoing

Coronary Artery Bypass Graft Surgery: Subgroup Analysis from the TRACER Trial. J Am Coll Cardiol.

E pub ahead of print pii: S0735-1097(13)06018-X. 10.1016/j.jacc.2013.10.048

Stewart R, Claes Held C, Brown R, Vedin O, Hag-

strom E, Lonn E, Armstrong P, Granger CB, Hoch-man J, Davies R, Soffer J, Wallentin L, White H.

Physical activity in patients with stable coronary heart disease: an international perspective.. Eur

Heart J in press http://dx.doi.org/10.1093eurheartj/eht258.

Toma M, Ezekowitz JA, Bakal JA, O’Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM,

Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection

fraction and mortality in patients with acute heart failure: Insights from the ASCEND-HF Trial. Eur J

Heart Fail in press.

Hess CN, Schulte PJ, Newby LK, Steg PG, Dalby

AJ, Schweiger MJ, Lewis BS, Armstrong PW, Califf RM, van de Werf F, Harrington RA. Duration of

eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk

patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS. Eur

Heart J Acute Cardiovasc Care. 2013; 2(3):246-55. (PMID 24222836) http://dx.doi.org/10.1177/204

8872612474922

Page 8

Publication Information

This newsletter is published

periodically as a service to

Canadian investigational sites. The

purpose is to provide information

of interest to individuals involved

in cardiovascular clinical trials

managed by the Canadian

VIGOUR Centre, University

of Alberta in Edmonton, Alberta,

Canada.

The VIGOUR (Virtual

Coordinating Centre for Global

Collaborative Cardiovascular

Research) group is an international

academic group committed to

advancing cardiovascular medicine

and enhancing patient care

worldwide. Its membership

includes: the Canadian VIGOUR

Centre (CVC), University of

Alberta, Edmonton, Alberta,

Canada; Green Lane Coordinating

Centre, Auckland, New Zealand;

National Health & Medical

Research Council – Clinical Trials

Centre, Sydney, Australia; Flinders

Medical Centre, Bedford Park,

Australia; Duke Clinical Research

Institute (DCRI), Duke University,

Durham, NC, USA; Leuven

Coordinating Centre, University

Hospital Gasthuisberg, Leuven,

Belgium; ECLA, Rosario,

Argentina, South America;

TANGO, Buenos Aires, Argentina,

South America; Uppsala Clinical

Research Centre, Uppsala, Sweden

Address for Inquiries:

2-132 Li Ka Shing Centre for Health Research Innovation

University of Alberta Edmonton, AB T6G 2E1

Canada Phone: 1-800-707-9098

Fax: (780) 492-0613 www.vigour.ualberta.ca

CANADIAN VIGOUR CENTRE

Selected CVC Presentations and Publications Since Last Issue

PW Armstrong

Kalli Belseck

Amanda Carapellucci

Robert Evans

Lyndsey Garritty

Halina Nawrocki

Jodi Parrotta

Dianne Payeur

Ellen Pyear

Carla Price

Paula Priest

Melisa Spaling

Tracy Temple

Canadian Cardiac Chronicle

Editorial Board:

Abstracts

Ezekowitz JA, Welsh RC, Weiss D, Gubbels C, Brass

N, Chan M, Keeble W, Khadour F, Knapp D, Sharma S,

Sookram SS, Tymchak W, Westerhout CM, Armstrong

PW. Providing Rapid Out Of Hospital Acute Cardio-

vascular Treatment (PRAOCT-3). Can J Cardiol 2013;

29 (10Suppl):S381-382.

Abualnaja S, Podder M, Hernandez A, McMurray JJ,

Armstrong PW, Ezekowitz JA. Does Atrial Fibrillation

Affect Outcomes In Patients Admitted With Acute

Heart Failure? Insights from the ASCEND-HF. Can J

Cardiol 2013; 29 (10 Suppl):S147-148.

Dianati-Maleki N, Van de Werf F, Goldstein P, Adgey J,

Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH,

Zheng Y, Armstrong PW. Incidence and Implications of

Aborted Myocardial Infarction in STREAM. Circulation

2013;128: A9297.

Dery JPP, Mahaffey K, Tricoci P, White H, Podder M,

Moliterno D, Harrington R, Chen E, Strony J, Van de

Werf F, Ziada KM, Held C, Aylward P, Armstrong PW,

Rao S. Arterial access site and outcomes in patients

undergoing percutaneous coronary intervention with

or without vorapaxar. Circulation 2013;128: A10742.

Jones S, Tricoci P, Huang Z, Moliterno DJ, Harrington

RA, Sinnaeve P, Strony J, Van de Werf F, White HD,

Held C, Armstrong PW, Aylward PE, Chen E, Patel

MR, Mahaffey KW. Vorapaxar in Non–ST-Segment

Elevation Acute Coronary Syndrome

Patients with Peripheral Artery Disease: Results from

TRACER. Circulation 2013; 128: A17939.

Bernacki GM, Alexander KP, Newby LK, Yang Q,

Schulte P, White HD, Ohman EM, Mahaffey KW, Shah

BR, Giugliano RP, Armstrong PW, Harrington RA,

Tricoci P, Van de Werf F, Alexander J, Califf RM. Lopes

RD. Trends in Enrollment, Patient

Characteristics, Treatments and Outcomes of Older

Adults with Non-ST-segment Elevation Acute

Coronary Syndromes (ACS) in Clinical Trials.

Circulation 2013;128:A9904.

Armaganijan L, Lopes R, Huang Z, Tricoci P, Held C,

Van de Werf F, Armstrong PW, Aylward PE, White

HD, Moliterno DJ, Wallentin L, Chen E, Harrington

RA, Strony J, Mahaffey KW. Efficacy and Safety of Vora-

paxar in Elderly Patients with Non–ST-Segment Eleva-

tion Acute Coronary Syndrome: Insights from the

TRACER Trial. Circulation 2013;128: A13198.

Tricoci P, Chen E, Neely ML, Warner A, Wong PH,

Sinnaeve P, Wallentin L, Jennings LK, Storey RF, Ayl-

ward PE, White HD, Van de Werf F, Armstrong PW,

Held C, Valgimigli M, Harrington RA, Strony J, Mahaffey

KW, Moliterno DJ. CYP2C19

Polymorphism and PON-1 Activity in NSTE ACS: Vora-

paxar Effect in Relation to Clopidogrel

Metabolism in the TRACER Trial. Circulation 2013;128:

A17658.

Bagai A, Huang Z, Lokhnygina Y, Harrington RA, Arm-

strong PW, Strony J, Chen E, White HD, Held C, Van

de Werf F, Wallentin L, Tricoci P, Mahaffey KW. Dif-

ferential Prognostic Implications of Peak Troponin

Level in Acute Coronary Syndrome Treated With and

Without Revascularization

Circulation 2013;128:A14033.

Halim S, Yang Q, Schulte P, Hochman J, Melloni C,

Mahaffey KW, Moliterno DJ, Harrington RA, White

HD, Armstrong PW, Ohman EM, Van de Werf F, Giu-

gliano RP; Newby LK. Evolution of Differences in

Women and Men with Non-ST-Segment

Elevation Acute Coronary Syndromes: Insights from

Clinical Trials over 15 years. Circulation 2013; 128:

A15834.

Welsh RC, Van de Werf F, Goldstein P, Gershlick AH,

Wilcox R, Danays T, Bluhmki E, Westerhout CM,

Armstrong PW. Impact of Rescue/Urgent

Angiography on Outcomes of ST-Elevation

Myocardial Infarction: Insights from STREAM.

Circulation 2013;128:A17925.

Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely

ML, McGuire DK, Cornel JH, Huber K,

Zamoryakhin D, White HD, Armstrong PW, Fox KA,

Prabhakaran D, Ohman EM. Outcomes in Women

Compared With Men in Patients With Unstable Angi-

na/Non-ST-Segment Elevation

Myocardial Infarction Managed Without

Revascularization: Insights From the TRILOGY ACS

Trial. Circulation 2013;128:A12130.

Lopes RD, Neely B, Ohman EM, Ardissino D, Hamm

C, Goodman SG, Bhatt DL, Brown EB, White HD,

Prabhakaran D, Martinez F, Nicolau JC, Fox KA, Arm-

strong PW, Roe MT. Timing, Profile, and Predictors of

Spontaneous Myocardial

Infarction Following a Non-ST-Segment Elevation

Acute Coronary Syndrome Event: Insights From the

TRILOGY-ACS Trial. Circulation.2013;128:A14972.

CVC gratefully acknowledges funding from the following:

Alere Inc.

Amylin Pharmaceuticals, LLC

CSL Behring LLC

GlaxoSmithKline Inc.

Hoffmann-La Roche

Merck & Co., Inc.

Regado Biosciences Inc.

Sanofi-aventis Recherche & Développement

Canadian Institute of Health Research

Mazankowski Alberta Heart Institute

University Hospital Foundation