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

NCT ID: NCT01304472

Last Updated: 2011-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-04-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prasugrel

Prasugrel 10mg per day

Group Type: EXPERIMENTAL

Prasugrel

Intervention Type: DRUG

Prasugrel 10mg per day

Clopidogrel

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Clopidogrel 150mg per day

Interventions

Prasugrel

Prasugrel 10mg per day

Intervention Type: DRUG

Clopidogrel

Clopidogrel 150mg per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years old
• Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
• High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
• Written Informed Consent

Exclusion Criteria

• History of bleeding diathesis
• History of active bleeding within 6 months before randomization
• Chronic oral anticoagulation treatment
• Contraindications to antiplatelet treatment
• Known platelet function disorders
• Acute coronary syndrome within 30 days before randomization
• Cardiogenic shock
• Planned Percutaneous Coronary Intervention in the next 30 days
• Cancer
• Haemodialysis
• Platelet count < 100000/μL
• Hematocrit < 30%
• High likelihood of being unavailable on the Day 28 visit
• History of stroke
• Known allergy to clopidogrel and/or prasugrel

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Alexopoulos

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dimitrios Alexopoulos

Pátrai, , Greece

Patras University Hospital Cardiology Department

Pátrai, , Greece

Countries

Greece

Other Identifiers

PATRASCARDIOLOGY-3

Identifier Type: -

Identifier Source: org_study_id