TR ial to Assess I mprovement in T herapeutic Outcomes by O ptimizing Platelet InhibitioN with Prasugrel TRITON-TIMI 38 TRITON-TIMI 38 AHA 2007 AHA 2007 Orlando, Florida Orlando, Florida Disclosure Statement Disclosure Statement : : The TRITON-TIMI 38 trial was supported by a research The TRITON-TIMI 38 trial was supported by a research grant to the Brigham and Women’s Hospital from Daiichi Sankyo grant to the Brigham and Women’s Hospital from Daiichi Sankyo Co. Ltd and Eli Lilly & Co. Co. Ltd and Eli Lilly & Co.
TR ial to Assess I mprovement in T herapeutic Outcomes by O ptimizing Platelet Inhibitio N with Prasugrel. TRITON-TIMI 38 AHA 2007 Orlando, Florida. - PowerPoint PPT Presentation
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
TRial to Assess Improvement in Therapeutic Outcomes by Optimizing
Platelet InhibitioN with Prasugrel
TRITON-TIMI 38TRITON-TIMI 38AHA 2007AHA 2007
Orlando, FloridaOrlando, Florida
Disclosure StatementDisclosure Statement: : The TRITON-TIMI 38 trial was supported by a research grant to the The TRITON-TIMI 38 trial was supported by a research grant to the
Brigham and Women’s Hospital from Daiichi Sankyo Co. Ltd and Eli Lilly & Co.Brigham and Women’s Hospital from Daiichi Sankyo Co. Ltd and Eli Lilly & Co.
Antiplatelet Therapy Antiplatelet Therapy for PCIfor PCI
• Dual antiplatelet Rx (ASA + thienopyridine) is standard of Dual antiplatelet Rx (ASA + thienopyridine) is standard of care:care:
Ticlopidine Ticlopidine ClopidogrelClopidogrel• Clinical need to improve on benefits observed with Clinical need to improve on benefits observed with
clopidogrelclopidogrel• PrasugrelPrasugrel
Novel thienopyridineNovel thienopyridineEfficient generation of active metaboliteEfficient generation of active metaboliteHigh levels of IPA achieved rapidlyHigh levels of IPA achieved rapidlyHigh IPA in High IPA in clopidogrelclopidogrel “hyporesponders”“hyporesponders”Encouraging Phase 2 dataEncouraging Phase 2 data
Healthy VolunteerHealthy VolunteerCrossover StudyCrossover Study
-20-20
00
2020
4040
6060
8080
100100
IPA
at
24 h
ou
rs (
%)
IPA
at
24 h
ou
rs (
%)
Response to Response to Prasugrel 60 mgPrasugrel 60 mg
Response to Response to Clopidogrel 300 mgClopidogrel 300 mg
1. To test the hypothesis that higher and less variable IPA prevents clinical ischemic events.
2. To evaluate the safety of a regimen that produces higher IPA.
These goals were achieved by evaluating the efficacy and safety of prasugrel compared to clopidogrel in mod/high risk patients with ACS undergoing PCI on a background of ASA.
Trial Trial OrganizationOrganization
Trial Leadership: TIMI Study GroupTrial Leadership: TIMI Study GroupEugene Braunwald,Chairman, Elliott M. Antman,PI, Eugene Braunwald,Chairman, Elliott M. Antman,PI, Stephen D. Wiviott, Gilles Montalescot, Carolyn H. McCabe, Stephen D. Wiviott, Gilles Montalescot, Carolyn H. McCabe, Sabina A. Murphy, Susan McHale Sabina A. Murphy, Susan McHale
Sponsors: Daiichi Sankyo and Eli Lilly Sponsors: Daiichi Sankyo and Eli Lilly J. Anthony Ware, Jeffrey Riesmeyer, William Macias, J. Anthony Ware, Jeffrey Riesmeyer, William Macias, James Croaning, Govinda Weerakkody, Francis Plat, James Croaning, Govinda Weerakkody, Francis Plat, Tomas Bocanegra Tomas Bocanegra
Data Center and Site Management: Quintiles IncData Center and Site Management: Quintiles Inc
Data Safety Monitoring BoardData Safety Monitoring Board David Williams (Chair) , Christophe Bode, Spencer King, David Williams (Chair) , Christophe Bode, Spencer King, Ulrich Sigwart, David DeMets Ulrich Sigwart, David DeMets
Mod-High Risk UA/NSTEMI (TRS > 3)STEMI: < 14 days (ischemia or Rx strategy)STEMI: Primary PCI
•Major Exclusion Criteria:– Severe comorbidity– Increased bleeding risk– Prior hemorrhagic stroke or any stroke < 3 mos– Any thienopyridine within 5 days– No exclusion for advanced age or renal function
KnownAnatomy
Enrollment: Enrollment: Nov 2004 - Jan 2007Nov 2004 - Jan 2007N = 13,608 (ITT)N = 13,608 (ITT)
Optimization of Prasugrel maintenance dosing in a minority of patients Optimization of Prasugrel maintenance dosing in a minority of patients may help improve the benefit : risk balancemay help improve the benefit : risk balance
Antiplatelet Therapy in ACSAntiplatelet Therapy in ACS
Placebo APTC CURE TRITON-TIMI 38Single
Antiplatelet RxDual
Antiplatelet RxHigher
IPA
ASAASA +
Clopidogrel ASA + Prasugrel
- 22%
- 20%
- 19%
+ 60% + 38% + 32%
Reduction in
IschemicEvents
Increase in
Major Bleeds
Publication of Primary ResultsPublication of Primary Results
Slides and Full Listing of Trial Participants at Slides and Full Listing of Trial Participants at www.TIMI.orgwww.TIMI.org