CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9,326 enrolled
Drug / intervention
Clopidogrel +2 moredrug
Likely dose
Clopidogrel 300 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00699998
NCT00699998Phase 3Completed
CompareCT.gov

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

Eli Lilly and Company·interventional·Posted Jun 18, 2008·Updated May 7, 2013

In Brief

A Phase 3 clinical trial evaluating Clopidogrel, Prasugrel, and 1 other intervention for Acute Coronary Syndrome. Completed, enrolled 9,326 participants across 688 sites in 53 countries.

Detailed Summary

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsDaiichi Sankyo Co., Ltd., Duke Clinical Research Institute

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.0 years ago

Interventions

Clopidogreldrug

300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Prasugreldrug

30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study

Commercially-available Aspirindrug

Low-dose aspirin, oral, as prescribed by physician through end of study