NCT01304472

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	Prasugrel	Prasugrel 10mg per day
DRUG	Clopidogrel	Clopidogrel 150mg per day

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-02-25
• Last updated: 2011-08-23

Locations

2 sites across 1 country: Greece