drugset / Trial / NCT01304472

Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

NCT01304472

Phase 3 Completed 25 enrolled University of Patras
RandomizedCrossoverSingle-blindTreatment

Summary

Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.

Timeline

Start
2011-02
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 150 mg
Subject Prasugrel Small molecule 10 mg