Document Detail


The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.
MedLine Citation:
PMID:  19699853     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features.
TRIAL DESIGN: TRA*CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least 1 year. The TRA*CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention.
CONCLUSION: TRA*CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.
Authors:
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial    
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:  327-334.e4     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00527943
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / drug therapy*
Adult
Blood Platelets / drug effects
Double-Blind Method
Humans
Lactones / pharmacology,  therapeutic use*
Platelet Aggregation Inhibitors / pharmacology,  therapeutic use*
Prospective Studies
Pyridines / pharmacology,  therapeutic use*
Receptor, PAR-1 / antagonists & inhibitors*
Research Design
Chemical
Reg. No./Substance:
0/Lactones; 0/Platelet Aggregation Inhibitors; 0/Pyridines; 0/Receptor, PAR-1; 0/vorapaxar
Investigator
Investigator/Affiliation:
Robert A Harrington / ; Frans Van de Werf / ; Paul W Armstrong / ; Phil Aylward / ; Bedford Park / ; Enrico Veltri / ; Kenneth W Mahaffey / ; David J Moliterno / ; John Strony / ; Lars Wallentin / ; Harvey D White / ; Rafael Diaz / ; Phil Aylward / ; Kurt Huber / ; Frans Van de Werf / ; Jose Carlos Nicolau / ; Paul W Armstrong / ; Juan Carlos Prieto / ; Daniel Isaza / ; Petr Widimsky / ; Peer Grande / ; Markku Nieminen / ; Gilles Montalescot / ; Christoph Bode / ; Lawrence Wong / ; Peter Ofner / ; Basil S Lewis / ; Giuseppe Ambrosio / ; Marco Valgimigli / ; Hisao Ogawa / ; Tetsu Yamaguchi / ; J Wouter Jukema / ; Jan H Cornel / ; Harvey D White / ; Jan Erik Nordrehaug / ; Witold Ruzyllo / ; Luis Providencia / ; Huay-Cheem Tan / ; Anthony Dalby / ; Park Seung-Jung / ; Amadeo Betriu / ; Angel Cequier / ; Claes Held / ; Mathias Pfisterer / ; Ming-Fong Chen / ; Timur Timurkaynak / ; Robert F Storey / ; Edmond Chen / ; Robert A Harrington / ; Michael P Hudson / ; A Michael Lincoff / ; Kenneth W Mahaffey / ; David A Morrow / ; Pierluigi Tricoci / ; David Whellan /
Comments/Corrections
Erratum In:
Am Heart J. 2010 May;159(5):932

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


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