drugset / Trial / NCT01115738

Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients

NCT01115738 ↗

Phase 2 Completed 282 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the effects of this combination on platelet inhibition will provide guidance to physicians on the use of prasugrel in patients who have already been pretreated with clopidogrel.

Timeline

Start
2010-05
Primary completion
2011-11
Completion
2011-11

Outcome

Missed primary endpoint

paper mg/prasugrel 60 mg (primary outcome) was 22.2 (-11.0 to 55.5; P=0.19; least squares mean PRU 57.9 versus 35.6, respectively). PMID 24065443 ↗

registry p = 0.188; Mean Difference (Final Values) 22.24 (95% CI -10.98 to 55.47) NCT01115738 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 600 mg Oral
Subject Prasugrel Small molecule 10 mg Oral