Document Detail


Evaluation of a novel antiplatelet agent for secondary prevention in patients with a history of atherosclerotic disease: design and rationale for the Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2 degrees P)-TIMI 50 trial.
MedLine Citation:
PMID:  19699854     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Thrombin potently activates platelets via interaction with the protease-activated receptor 1. SCH 530348 is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin via antagonism of the protease-activated receptor 1. Because SCH 530348 does not interfere with other pathways for hemostasis, it is possible that SCH 530348 reduces thrombosis with less increase in bleeding than do other potent antiplatelet agents.
STUDY DESIGN: TRA 2 degrees P-TIMI 50 is a phase III, randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the efficacy and safety of SCH 530348 during long-term treatment of patients with established atherosclerotic disease receiving standard therapy (up to 27,000). Eligible patients with a history of myocardial infarction, ischemic stroke, or peripheral arterial disease are randomized 1:1 to SCH 530348 2.5 mg daily or matched placebo until the end of study. Randomization is stratified by the qualifying disease and planned use of a thienopyridine. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, or urgent coronary revascularization. The major secondary end point is the composite of cardiovascular death, myocardial infarction, or stroke. The evaluation of long-term safety includes bleeding defined by the GUSTO and TIMI criteria. Recruitment began in September 2007. The trial will continue until 2,279 primary end points and 1,400 secondary end points are recorded with expected completion in 36 to 44 months from first enrollment.
CONCLUSIONS: TRA 2 degrees P-TIMI 50 is evaluating whether a new approach to platelet inhibition via interruption of thrombin-mediated platelet activation reduces major cardiovascular events with a favorable safety profile in patients with established atherosclerosis.
Authors:
David A Morrow; Benjamin M Scirica; Keith A A Fox; Gail Berman; John Strony; Enrico Veltri; Marc P Bonaca; Polly Fish; Carolyn H McCabe; Eugene Braunwald;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  158     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-08-24     Completed Date:  2009-10-08     Revised Date:  2010-12-20    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  335-341.e3     Citation Subset:  AIM; IM    
Affiliation:
TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA. dmorrow@partners.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00526474
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Adult
Atherosclerosis / drug therapy,  prevention & control*
Double-Blind Method
Hemorrhage / chemically induced
Humans
Lactones / pharmacology,  therapeutic use*
Platelet Activation / drug effects
Platelet Aggregation Inhibitors / pharmacology,  therapeutic use*
Pyridines / pharmacology,  therapeutic use*
Receptor, PAR-1 / antagonists & inhibitors*
Research Design
Treatment Outcome
Chemical
Reg. No./Substance:
0/Lactones; 0/Platelet Aggregation Inhibitors; 0/Pyridines; 0/Receptor, PAR-1; 0/vorapaxar
Investigator
Investigator/Affiliation:
Eugene Braunwald / ; Carolyn H McCabe / ; David A Morrow / ; Benjamin M Scirica / ; Marc P Bonaca / ; Polly Fish / ; Allan Skene / ; Karen Hill / ; Lucy Bennett / ; Gail Berman / ; John Strony / ; Enrico Veltri / ; Ann Kilian / ; Bo Yang / ; Keith A A Fox / ; Philip Aylward / ; Jean-Pierre Bassand / ; Amadeo Betriu / ; Henri Bounameaux / ; Ramon Corbalan / ; Mark Creager / ; Anthony Dalby / ; Gaetano De Ferrari / ; Mikael Dellborg / ; Rainer Dietz / ; Shinya Goto / ; Peer Grande / ; Paul Gurbel / ; Graeme Hankey / ; Daniel Isaza / ; Peder Jensen / ; Robert Kiss / ; Basil Lewis / ; Piera Merlini / ; David Moliterno / ; Joao Morais / ; Jose Carlos Nicolau / ; Markku Nieminen / ; Dennis Nilsen / ; Jeffrey Olin / ; Ton Oude Ophuis / ; Ernesto Paolasso / ; Max Pichler / ; Yukito Shinohara / ; Jindrich Spinar / ; Phil Teal / ; Michal Tendera / ; Pierre Theroux / ; Lars Thomassen / ; Frans Van de Werf / ; Harvey White / ; Robert Wilcox / ; Mark Alberts / ; Sebastian Ameriso / ; Hans Diener / ; Steven Feske / ; Jay Mohr / ; Michael Welch / ; Stephen D Wiviott / ; Eric Awtry / ; Clifford Berger / ; Akshay Desai / ; Eli Gelfand / ; David Leeman / ; Mark Link / ; Natalia Rost / ; Rick Ruberg / ; Scott Silverman / ; Joseph Vita /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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