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Effect of low-dose intracoronary alteplase during primary PCI on microvascular
obstruction in acute myocardial infarctionColin Berry on behalf of the T-TIME
InvestigatorsLBS.04. Preserving Brain & Heart in Acute Care Cardiology
American Heart AssociationChicago, 11 November 2018
Proximal occlusion of the left anterior
descending coronary artery
Anterior STEMI
Excellent stent result
Normal coronary flow
PCI success?
Successful primary PCI
MVO
Failed myocardial reperfusionhalf of all patients
Contrast - enhanced MRI
Bright infarct area Dark MVO core
Standard ‘cine’ MRI
Design• Aim: To determine if low-dose intracoronary alteplase infused early after
coronary reperfusion reduces failed myocardial reperfusion (MVO)
• Design: Multicenter, parallel group, 1:1:1 randomized, dose-ranging trial in primary PCI.
• Placebo, alteplase 10 mg, alteplase 20 mg.
• Inclusion: Acute STEMI due to a proximal - mid vessel occlusion of a major coronary artery @ ≤6 hours from symptom onset.
• Exclusions: Rentrop ≥2 collaterals, contra-indications to lytic therapy
Culprit coronary artery
Drug delivered after reperfusion & before stenting, proximal to the culprit lesion 20 ml of study drug manually infused during 5 - 10 min.
Aorta
Guide & infusion catheterThrombus-laden lesion
Baseline characteristics21 Dec 2017, enrolment discontinued, n=440
Randomly assigned, n (%)
Characteristics, n (%)* Placebo
n = 151
Alteplase, 10 mg
n = 144
Alteplase, 20 mg
n = 145Age, years 60.7 (11.0) 59.6 (10.3) 61.2 (9.7)
Female sex 24/151 (15.9) 20/144 (13.9) 22/145 (15.2)
Race, white 143/151 (94.7) 134/144 (93.1) 136/145 (93.8)
Infarct locationAnterior 65/151 (43.0) 62/144 (43.1) 64/145 (44.1)
Medical historyHypertension 47/151 (31.1) 45/144 (31.2) 49/145 (33.8)
Diabetes mellitus 19/151 (12.6) 19/144 (13.2) 18/145 (12.4)
SmokingCurrent 75/151 (49.7) 72/144 (50.0) 62/145 (42.8)
Myocardial infarction 6/151 (4.0) 6/144 (4.2) 8/145 (5.5)
Stroke or transient ischemic attack 2/151 (1.3) 1/144 (0.7) 2/145 (1.4)
Pre-existing maintenance medication Aspirin 27/151 (17.9) 17/144 (11.8) 22/145 (15.2)
Symptom onset to reperfusion, hours:mins 2:36 (2:03, 3:36) 2:50 1:55, 4:06) 2:44 (2:01, 3:49)
Door to balloon time, mins 24 (19, 35) 23 (19, 37) 25 (19, 34)
Procedure characteristicsCardiac MRI performed
Characteristics, n (%)* Placebo
n = 137
Alteplase, 10 mg
n = 131
Alteplase, 20 mg
n = 132Infarct-related artery - left anterior descending 61/137 (44.5) 61/131 (46.6) 60/132 (45.5)
Infarct artery diameter, mean (SD), mm 3.2 (0.4) 3.2 (0.5) 3.2 (0.4)
TIMI flow grade at initial angiography0 (No flow) 117/137 (85.4) 103/131 (78.6) 103/132 (78.0)
1 (Minimal flow) 3/137 (2.2) 13/131 (9.9) 14/132 (10.6)
2/3 (2 = Slow but complete, 3 = Normal flow) 17/137 (12.4) 15/131 (11.5) 15/132 (11.4)
Mode of reperfusion Aspiration thrombectomy 37/137 (27.0) 42/131 (32.3) 40/132 (30.3)
Balloon angioplasty 100/137 (73.0) 88/131 (67.7) 91/132 (68.9)
Total number of stents deployed0 1/137 (0.7) 2/131 (1.4) 1/132 (0.8)
1 92/137 (67.2) 88/131 (67.2) 99/132 (75.0)
2 40/137 (29.2) 28/131 (21.4) 28/132 (21.2)
≥3 4 /137 (2.9) 10/131 (7.6) 4/132 (3.0)
Total length of stents deployed, mean (SD), mm 33.5 (13.8) 35.7 (15.3) 32.0 (14.0)
Post-stent dilatation 119/137 (86.9) 116/131 (88.5) 115/132 (87.1)
Anti-thrombotic therapyCardiac MRI performed
Characteristics, n (%)* Placebo
n = 137
Alteplase, 10 mg
n = 131
Alteplase, 20 mg
n = 132Acute therapy following the first medical contactAspirin loading dose (≥ 300 mg) 119/137 (86.9) 118/131 (90.1) 112/132 (84.8)
Additional anti-platelet medicationNone 15/137 (10.9) 10/131 (7.6) 17/132 (12.9)
Clopidogrel 43/137 (31.4) 48/131 (36.6) 51/132 (38.6)
Ticagrelor 76/137 (55.5) 68/131 (51.9) 60/132 (45.5)
Prasugrel 3/137 (2.2) 5/131 (3.8) 4/132 (3.0)
Unfractionated heparin (U), median (IQR) 10,000
(7000, 12,250)
10,000
(7500, 13,000)
10,000
(7000, 13,000)IV or intracoronary glycoprotein IIb/IIIa antagonist 13/134 (9.7) 27/127 (21.3) 21/129 (16.3)
Study treatmentDrug administered 137/137 (100.0) 129/131 (98.5) 132/132 (100.0)
Study drug given according to protocol 136/137 (99.3) 127/129 (98.4) 131/132 (99.2)
Duration of study drug infusion, min, mean (SD) 6.4 (1.9) 6.6 (2.0) 6.6 (2.0)
Primary outcomeMicrovascular obstruction, days 2 - 7
00.5
11.5
22.5
33.5
4
Microvascular obstruction
Placebo Alteplase, 10 mgPlacebo Alteplase, 20 mg
3.5 (5.8) 2.3 (4.3)
P = 0.32 %LV mass
(MRI)
i
00.5
11.5
22.5
33.5
4
Microvascular obstruction
Placebo Alteplase, 10 mg Alteplase, 20 mg
%LV mass
(MRI)
*
* Secondary outcome
3.5 (5.8) 2.3 (4.3) 2.6 (4.5)
P = 0.28
Primary outcomeMicrovascular obstruction, days 2 - 7
iInteractions tests, pre-specified baseline characteristics
• Sex, age, MI location, smoking, initial TIMI flow grade, anti-platelet therapy, p > 0.05.
• Ischaemic time (p = 0.06) Patients presenting 4 – 6 hrs, the mean difference in MVO: alteplase 20 mg group (n=27) vs. placebo group (n=26) = 1.12 (95% CI: 0.42, 1.82), p=0.002.
Primary outcomeMicrovascular obstruction, days 2 - 7
Secondary outcomesTroponin AUC
n = 317
Alteplase relative difference
20 mg vs. placebo: 1.53 (95% CI: 1.12, 2.11), p= 0.008
(10 mg, 20 mg) vs. placebo: 1.53 (95% CI: 1.16, 2.01), p=0.002
Alteplase20 mg10 mg
Placebo
i
Secondary outcomesAngiography, ECG, NT-proBNP, MRI, QoL
Treatment groupAngiography outcomes Placebo
(n=151)
Alteplase, 10 mg
(n=144)
Alteplase, 20 mg
(n=145)Coronary angiogram (n=440)TIMI flow grade after PCI0 (No flow) 0/151 (0.0) 1/144 (0.7) 1/145 (0.7)1 (Minimal flow) 6/151 (4.0) 6/144 (4.2) 3/145 (2.1)2 (Slow but complete) 20/151(13.2) 22/144 (15.3) 29/145 (20.0)3 (Normal Flow) 125/151 (82.8) 115/144 (79.9) 112/145 (77.2)
TIMI myocardial perfusion grade after PCI0 (No blush) 46/151 (30.5) 62/144 (43.1) 49/145 (33.8)1 (Incomplete clearance) 11/151 (7.3) 2/144 (1.4) 9/145 (6.2)2 (Persistent) 51/151 (33.8) 48/144 (33.3) 49/145 (33.8)3 (Normal blush and clearance) 43/151 (28.5) 32/144 (22.2) 38/145 (26.2)
Day 2-7: End of PCI, TIMI Flow Grade, Myocardial Perfusion Grade, Frame Count, Thrombus grade; ECG (ST-segment resolution @ 60 min; NT-proBNP; Cardiac MRI (AAR, MVO, myocardial haemorrhage, myocardial salvage, LVEF, volumes).
3 months: ECG Sylvester score, NT-proBNP, MRI outcomes, QoL.
i
Secondary outcomesHealth outcomes (safety)
Treatment group (as treated)
Outcome* Placebo
(n=149)
Alteplase 10mg
(n=140)
Alteplase 20mg
(n=146)
p-value
CV death, non-fatal MI, unplanned hospitalization for stroke or TIA (MACCE) 5/149 (3.4) 6/140 (4.3) 6/146 (4.1) 0.91
CV death, non-fatal MI or unplanned hospitalization for heart failure (MACE) 15/149 (10.1) 18/140 (12.9) 12/146 (8.2) 0.43All-cause death 1/149 (0.7) 3/140 (2.1) 3/146 (2.1) 0.58Cardiac death 1/149 (0.7) 3/140 (2.1) 2/146 (1.4) 0.45Myocardial infarction associated with revascularization procedures (Type 4 or 5) 2/149 (1.3) 3/140 (2.1) 1/146 (0.7) 0.54
Fatal or non-fatal myocardial infarction 3/149 (2.0) 6/140 (4.3) 5/146 (3.4) 0.51Stroke or transient ischemic attack 0/149 (0.0) 0/140 (0.0) 2/146 (1.4) 0.22Heart failure requiring unplanned hospitalization 13/149 (8.7) 13/140 (9.3) 8/146 (5.5) 0.43All-cause death or heart failure 14/149 (9.4) 15/140 (10.7) 11/146 (7.5) 0.64All Bleeding
Minor bleeds (BARC 1 – 2) 4/149 (2.6) 3/140 (2.1) 3/146 (2.1) 0.32Major bleeds (BARC 3 – 5) 0/149 (0.0) 1/140 (0.7) 1/146 (0.7) 0.55
Bleeding on day of procedureMinor bleeds (BARC 1 – 2) 2/149 (1.3) 2/140 (1.4) 3/146 (2.1) 0.90Major bleeds (BARC 3 – 5) 0/149 (0.0) 1/140 (0.7) 1/146 (0.7) 0.55
*Data reported as number (n) and percentage of treatment group (%). Treatment groups are as treated for clinical events. BARC = Bleeding Academic Research Consortium, CV = Cardiovascular, MACE = major adverse cardiac events, MACCE = Major adverse cardiac and cardiovascular events; MI = Myocardial infarction, TIA = Transient Ischemic attack.
Conclusions1. In patients with acute STEMI @ <6 hours, low-dose
intracoronary alteplase given during the primary PCI compared with placebo did not reduce microvascular obstruction. Troponin AUC was increased.
2. The results do not support this therapeutic strategy, as designed.
3. MVO remains an unmet therapeutic need.
AcknowledgementsPatients, all staff, funders
Peter J. McCartney MRCP; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Hany Eteiba FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Annette M. Maznyczka MRCP; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Margaret McEntegart FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; John P. Greenwood FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust, Leeds; no personal compensation; Douglas F. Muir FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough; Saqib Chowdhary FRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester; Anthony H. Gershlick FRCP; University of Leicester, Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Clare Appleby FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust; James M. CottonFRCP; Wolverhampton University Hospital NHS Trust; Andrew Wragg FRCP; Barts Health NHS Trust, London; Nick Curzen FRCP; University Hospital Southampton Foundation Trust, Southampton; Keith G. Oldroyd MD; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Mitchell LindsayFRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; J. Paul Rocchiccioli FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Aadil Shaukat FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Richard Good FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Stuart Watkins FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Keith RobertsonFRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Christopher Malkin FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust, Leeds; Lynn Martin BN; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Lynsey Gillespie PhD; Greater Glasgow and Clyde Health Board; Thomas J. Ford FRACP; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Mark C. Petrie FRCP; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Peter W. MacfarlaneDSc; Electrocardiology Core Laboratory, University of Glasgow; unsalaried (Honorary Staff), no personal compensation.R. Campbell Tait FRCPath; Department of Haematology, Royal Infirmary, Glasgow; Paul Welsh PhD; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Naveed Sattar FMedSci; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Robin A. Weir MD;University Hospital Hairmyres, East Kilbride; Keith A. Fox FRCP; University of Edinburgh, Edinburgh; Ian Ford PhD; Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, UK; Alex McConnachie PhD; Robertson Centre for Biostatistics, Glasgow Clinical Trials Unit, University of Glasgow; Colin Berry FRCP; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Liverpool Heart and Chest Hospital NHS Foundation TrustSuneil Aggarwal FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Turab Ali FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Fiona Andrews BN; Liverpool Heart and Chest Hospital NHS Foundation Trust: Nicola Browning PhD; Liverpool Heart and Chest Hospital NHS Foundation Trust: Timothy A. Fairbairn FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Ruth Hardwick MPharm; Liverpool Heart and Chest Hospital NHS Foundation Trust: J Hasleton FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Babu Kunadian FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Pradeep Magapu FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Nick Palmer FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Rodney Stables FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: Clive Taylerson; Liverpool Heart and Chest Hospital NHS Foundation Trust: Hoi Tong HCPC; Liverpool Heart and Chest Hospital NHS Foundation Trust: Sophie Twiss BN; Liverpool Heart and Chest Hospital NHS Foundation Trust; Periaswamy Velavan FRCP; Liverpool Heart and Chest Hospital NHS Foundation Trust: University Hospital Southampton Foundation TrustKaren Banks RN; University Hospital Southampton Foundation Trust; Simon Corbett FRCP; University Hospital Southampton Foundation Trust; Michael Mahmoudi FRCP; University Hospital Southampton Foundation Trust; Zoe Nicholas BSc; University Hospital Southampton Foundation Trust; James Wilkinson FRCP; University Hospital Southampton Foundation Trust; Leeds University Hospitals NHS TrustMatthew Allan MRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; Michelle Anderson RN; Leeds University and Leeds Teaching Hospitals NHS Trust; Daniel J Blackman MD MRCP; Leeds Teaching Hospitals NHS Trust; Jonathan Blaxill FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; Michael Cunnington MD; Leeds University and Leeds Teaching Hospitals NHS Trust; Vivek Kodoth FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; John Kurian FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; unSteven Lindsay FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; unChristopher Malkin FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; Jim Mclenachan FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust; Kathryn Somers RN; Leeds University and Leeds Teaching Hospitals NHS Trust; Murgu Veersamy FRCP; Leeds University and Leeds Teaching Hospitals NHS Trust;
Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust;Reenamol Abraham RN; University of Leicester, Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; David Adlam FRCP; University of Leicester, Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Stephen Coleman BPharm; Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Ian Hudson FRCP; Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Andrew Ladwiniec MRCP; Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Gerald P. McCann MD; University of Leicester, Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Emma Parker RN; Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Elved Roberts MD; Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Joanne Wormleighton DCR(R); Leicester Biomedical Research centre, University Hospitals of Leicester NHS Trust; Wythenshawe Hospital, Manchester University NHS Foundation TrustEltigani Abdelaal MRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Hussain Contractor FRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Beatriz Duran BS Pharm; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Robin Egdell FRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Susan Ferguson BN; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Sarra Giannopoulou BN; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Sanjay Sastry FRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Jaydeep Sarma FRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Matthias Schmitt FRCP; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Sophie Quinn BN; Wythenshawe Hospital, Manchester University NHS Foundation Trust; Barts Health NHS Trust, LondonAndrew Archbold FRCP; Barts Health NHS Trust, London; Mervyn Andiapen DN; Barts Health NHS Trust, London; Charity Evwierhoma BN; Barts Health NHS Trust, London; Ajay Jain FRCP; Barts Health NHS Trust, London; Dan Jones FRCP; Barts Health NHS Trust, London; Simon Kennon FRCP; Barts Health NHS Trust, London; James Moon FRCP; Barts Health NHS Trust, London; Anthony Mathur FRCP; Barts Health NHS Trust, London; Amy Richards BSc; Barts Health NHS Trust, London; Alexander Sirker FRCP; Barts Health NHS Trust, London; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, MiddlesbroughDavid Austin FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Mark de Belder FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Justin Carter MRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Nicola Cunningham BSc (Hons); The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Rachel Dale HCPC; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Jim Hall FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Stephanie Mack BSc (Hons); The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Tracy Manders RN; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Neil Maredia MD; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Karen McLeod BSc (Hons); The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Luca Settimo PhD Pharm; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Andrew Sutton FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Neil Swanson FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Paul Williams FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: Robert Wright FRCP; The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough: New Cross Hospital, Wolverhampton University Hospital NHS TrustVictoria Cottam BN; New Cross Hospital, Wolverhampton University Hospital NHS Trust; Elizabeth Radford; New Cross Hospital, Wolverhampton University Hospital NHS Trust; Ben Wrigley FRCP; New Cross Hospital, Wolverhampton University Hospital NHS Trust; Freeman Hospital, The Newcastle Upon Tyne Hospital NHS Foundation TrustRajiv Das FRCP; Freeman Hospital, The Newcastle Upon Tyne Hospital NHS Foundation Trust; Samantha Jones BN; Freeman Hospital, The Newcastle Upon Tyne Hospital NHS Foundation Trust; Vera Wealleans BN; Freeman Hospital, The Newcastle Upon Tyne Hospital NHS Foundation Trust; Royal Infirmary of Edinburgh, NHS LothianNick Cruden FRCP; Royal Infirmary of Edinburgh, NHS Lothian; Laura Flint BN; Royal Infirmary of Edinburgh, NHS Lothian; Ruaridh Buchan MPharm; Royal Infirmary of Edinburgh, NHS Lothian; University Hospitals Bristol NHS Foundation TrustChiara Bucciarelli-Ducci FRCP; University of Bristol and Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust; Tom Johnson FRCP; University Hospitals Bristol NHS Foundation Trust; Vincy Johny BN; University Hospitals Bristol NHS Foundation Trust; Liz McCullagh B.Pharm; University Hospitals Bristol NHS Foundation Trust;
Participating Sites:David Corcoran MRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Andrew Davie FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Stuart Hood FRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Tom Krysztofiak MRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Victoria McNulty MPharm(Hons); West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Vanessa Orchard HCPC; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Jackie Wales FIBMS; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK;
Clinical Event Committee: Robin A. Weir MRCP; University Hospital Hairmyres Hospital, NHS Lanarkshire, UK; Aengus Murphy MD; University Hospital Monklands, NHS Lanarkshire, UK; Colin J. Petrie PhD; University Hospital Monklands, NHS Lanarkshire, UK; Eleanor Dinnett MBChB; Robertson Centre for Biostatistics, University of Glasgow;
Independent Data and Safety Monitoring Committee:Gary A. Ford MB BChir; University of Oxford, UK; unChim C. Lang FRCP, University of Dundee, UK; John Norrie MSc; University of Edinburgh, UK;
Trial Steering CommitteeKeith A. Fox FRCP; University of Edinburgh, UK; Colin Berry FRCP; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK; Rajesh Kharbanda FRCP; Oxford University Hospitals NHS Foundation Trust; Catherine Labinjoh FRCP; Forth Valley Royal Hospital, NHS Forth Valley; Gordon Baird MRCGP; Stranraer; Sandra Pairman BN; Golden Jubilee National Hospital;
Trial ManagementDavid Jamieson PhD; Robertson Centre for Biostatistics, University of Glasgow; Sarah Weeden PhD; Robertson Centre for Biostatistics, University of Glasgow; Jurgen Van-Melckebeke BSc; Project Management Unit, Glasgow Clinical Research Facility, Greater Glasgow and Clyde Health Board; Elizabeth Douglas PhD; Clinical Trials Pharmacy, Clinical Research and Development, Greater Glasgow and Clyde Health Board; Pamela Surtees; Clinical Trials Pharmacy, Clinical Research and Development, Greater Glasgow and Clyde Health Board; Barbara Ross BSc (Hons); Clinical Research and Development, Greater Glasgow and Clyde Health Board; Gemma Brindley PhD; Clinical Research and Development, Greater Glasgow and Clyde Health Board; Sheila McGowan PhD; Clinical Research and Development, Greater Glasgow and Clyde Health Board; Emma Jane Gault M.A. (Hons); College of Medical, Veterinary and Life Sciences, University of Glasgow; Debra Stuart PhD; College of Medical, Veterinary and Life Sciences, University of Glasgow; Maureen Travers PhD; R&D Office, Clinical Research and Development, Greater Glasgow and Clyde Health Board; Marc Jones, PhD; Pharmacovigilance Office, Clinical Research and Development, Greater Glasgow and Clyde Health Board; Sharon Kean; Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, UK; Caroline Watson, PhD; R&D Governance, Clinical Research and Development, Greater Glasgow and Clyde Health Board; Emma Miller; Project Management Unit, Glasgow Clinical Research Facility, Greater Glasgow and Clyde Health Board; Eamonn Bolger BSc, College of Medical, Veterinary and Life Sciences, University of Glasgow; Gillian Thomson, Project Management Unit, Glasgow Clinical Research Facility, Greater Glasgow and Clyde Health Board; Elaine Butler; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; Josephine Cooney; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; Julie Kennedy MSc; Electrocardiology Core Laboratory, University of Glasgow; Emma Leishman BSc; Department of Haematology, Royal Infirmary, Glasgow; Jaclyn Carberry MBChB (Hons); Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; David Corcoran MRCP; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK; Aleksandra Radjenovic PhD; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; We acknowledge all of the other clinical staff and the patients who participated in this project.
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