Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity

Study Overview
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Brief Summary
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The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.

Official Title
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150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention

Conditions
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Stable Angina Pectoris, Ad Hoc Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: clopidogrel
* Drug: clopidogrel plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clopidogrel-naïve stable angina pectoris (CCS I-III) Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation Exclusion Criteria: Acute coronary syndrome (STEMI, NSTEMI or unstable angina) Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks Contraindication to antiplatelet therapy Significant LM stenosis PCI due to instent restenosis Lesion located in bypass grafts Stroke in past one year Reduced life expectancy

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel | |
| Experimental: 2<br>Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days | Drug: clopidogrel<br>* 150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year<br>|
| Active Comparator: 3<br>Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel | Drug: clopidogrel plus placebo<br>* 75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Academic Research Consortium (ARC) definite / probable stent thrombosis |  | 12 months | 
| Cardiac death and non-fatal myocardial infarction |  | 12 months | 
| Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding |  | 12 months | 
| 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer |  | 25 +/-2 days | 
| VASP-PRI |  | 25 +/-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents