Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Primary Purpose
Coronary Artery Disease (CAD)
Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Prasugrel
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease (CAD) focused on measuring coronary angioplasty, clopidogrel resistance, prasugrel
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
Sites / Locations
- Dimitrios Alexopoulos
- Patras University Hospital Cardiology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prasugrel
Clopidogrel
Arm Description
Prasugrel 10mg per day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01304472
First Posted
February 24, 2011
Last Updated
August 21, 2011
Sponsor
University of Patras
1. Study Identification
Unique Protocol Identification Number
NCT01304472
Brief Title
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Official Title
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
coronary angioplasty, clopidogrel resistance, prasugrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel
Arm Type
Experimental
Arm Description
Prasugrel 10mg per day
Arm Title
Clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Prasugrel 10mg per day
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 150mg per day
Primary Outcome Measure Information:
Title
Change in Platelet Reactivity
Description
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
Time Frame
At 14 and 28 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dimitrios Alexopoulos
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Patras University Hospital Cardiology Department
City
Patras
ZIP/Postal Code
26500
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
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