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

Coronary Artery Disease (CAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304472
• Other study ID #: PATRASCARDIOLOGY-3
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2011
• Last updated: August 21, 2011
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: August 2011
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Prasugrel
Prasugrel 10mg per day
• Clopidogrel
Clopidogrel 150mg per day

Locations

Country	Name	City	State
Greece	Dimitrios Alexopoulos	Patras
Greece	Patras University Hospital Cardiology Department	Patras

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Platelet Reactivity	Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization	At 14 and 28 days after randomization	No