CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Prasugrel +1 moredrug
Likely dose
Prasugrel 10 mg orally once daily for 14 days OR Clopidogrel 150 mg orally once daily for 14 days (after 900-mg clopidogrel loading dose)AI-extracted
Key inclusion· 3
  • ✓Acute coronary syndrome (ACS) with planned 900-mg clopidogrel loading dose
  • ✓Age 18–85 years
  • ✓Able to provide informed consent
Key exclusion· 9
  • ✕STEMI (ST-elevation myocardial infarction)
  • ✕Cardiogenic shock
  • ✕Refractory ventricular arrhythmias
  • ✕NYHA Class IV congestive heart failure

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

Search/NCT00385944
NCT00385944Phase 2Completed
CompareCT.gov

A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation

Eli Lilly and Company·interventional·Posted Oct 11, 2006·Updated Sep 16, 2010

In Brief

A Phase 2 clinical trial evaluating Prasugrel and Clopidogrel for Acute Coronary Syndrome. Completed, enrolled 56 participants across 2 sites.

Detailed Summary

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesFrance
CollaboratorsDaiichi Sankyo

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2006
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.7 years ago

Interventions

Prasugreldrug

Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.

Clopidogreldrug

Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.