Document Detail


Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial.
MedLine Citation:
PMID:  20598967     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel for patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) regardless of in-hospital management strategy. Prasugrel-a thienopyridine adenosine diphosphate receptor antagonist that provides higher and less variable levels of platelet inhibition than clopidogrel-has demonstrated benefit when used to treat ACS patients undergoing percutaneous coronary intervention. However, the optimal approach to antiplatelet therapy for high-risk, medically managed NSTE ACS patients remains uncertain, as these patients have not been the focus of previous clinical trials of these therapies. TRILOGY ACS is a phase 3, randomized, double-blind trial enrolling approximately 10,300 NSTE ACS patients within 10 days of presentation with either unstable angina or NSTE myocardial infarction who are not intended to undergo revascularization procedures for their index event. Patients will be randomly allocated to prasugrel + aspirin versus clopidogrel + aspirin for a median duration of 18 months. A reduction in the maintenance dose of prasugrel for elderly patients (age >or=75 years) and those with body weight <60 kg is planned. The primary composite efficacy end point will be time to first occurrence of cardiovascular death, myocardial infarction, or stroke in patients aged <75 years. If the superiority of prasugrel is established in patients aged <75 years, the treatment arms will then be compared for all subjects (including those aged >or=75 years). TRILOGY ACS is the largest randomized clinical trial to date focusing exclusively on medically managed NSTE ACS patients and will provide important information regarding the optimal approach to oral antiplatelet therapy for this high-risk, understudied population.
Authors:
Chee Tang Chin; Matthew T Roe; Keith A A Fox; Dorairaj Prabhakaran; Debra A Marshall; Helene Petitjean; Yuliya Lokhnygina; Eileen Brown; Paul W Armstrong; Harvey D White; E Magnus Ohman;
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  160     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-05     Completed Date:  2010-08-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  16-22.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) 2010 Mosby, Inc. All rights reserved.
Affiliation:
Duke Clinical Research Institute, Durham, NC, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00699998
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Aged
Angina, Unstable / drug therapy*,  mortality,  physiopathology
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Electrocardiography*
Follow-Up Studies
Humans
Middle Aged
Myocardial Infarction / drug therapy*,  mortality,  physiopathology
Piperazines / administration & dosage,  therapeutic use*
Platelet Aggregation Inhibitors / therapeutic use*
Receptors, Purinergic P2 / antagonists & inhibitors
Survival Rate
Thiophenes / administration & dosage,  therapeutic use*
Ticlopidine / administration & dosage,  analogs & derivatives*,  therapeutic use
Time Factors
Treatment Outcome
World Health
Chemical
Reg. No./Substance:
0/Piperazines; 0/Platelet Aggregation Inhibitors; 0/Receptors, Purinergic P2; 0/Thiophenes; 0/prasugrel; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel
Investigator
Investigator/Affiliation:
E Magnus Ohman / ; Matthew T Roe / ; Paul W Armstrong / ; Keith A A Fox / ; Debra A Marshall / ; Helene Petitjean / ; Dorairaj Prabhakaran / ; Harvey D White / ; Frans Van de Werf / ; Andrzej Budaj / ; Bernard J Gersh / ; Gilles Montalescot / ; Stuart J Pocock / ; Robert G Wilcox / ; David O Williams / ; Michael Wilson / ; Philip E Aylward / ; Jean-Pierre Bassand / ; Deepak L Bhatt / ; William E Boden / ; Victor R Castillo / ; Terrance Chua / ; Mircea Cinteza / ; Peter Clemmensen / ; Ramon Corbalan / ; Jan-Hein Cornel / ; Anthony J Dalby / ; David Erlinge / ; David Foley / ; Vladimir Gasparovic / ; Shaun Goodman / ; Shmuel Gottlieb / ; Assen Goudev / ; Nikolay Gratsiansky / ; Paul Gurbel / ; Christian W Hamm / ; Judith S Hochman / ; Kurt Huber / ; Myung Ho Jeong / ; Jose Luis Leiva-Pons / ; Jose Lopez-Sendon / ; Thomas F Luscher / ; Felipe Martinez / ; Darren K McGuire / ; Bela Merkely / ; Walter Mogrovejo / ; José C Nicolau / ; Ali Oto / ; Gregory Pavlides / ; Luis Providencia / ; Witold Ruzyllo / ; Piyamitr Sritara / ; Mikko Syvanne / ; Grace Topacio / ; Chuen-Den Tseng / ; Freek Verheugt / ; Petr Widimsky / ; Stephen D Wiviott / ; Robaayah Zambahari / ; Zhu Jun-Ren / ; Rajendra Mehta / ; Eileen Brown / ; Yuliya Lokhnygina / ; Stacy Woodard /

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