Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function

Study Overview
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Brief Summary
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Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation. This study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.

Official Title
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Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Clopidogrel
* Drug: Clopidogrel
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient with an indication for elective coronary angiography with or without PCI Exclusion Criteria: major hemorrhagic diathesis or active bleeding acute myocardial infarction (MI) within 14 days of enrolment unstable angina with ST-segment changes >1 mm in at least two contiguous electrocardiographic leads at rest or a troponin I level >0.06 microg/L within 14 days of enrolment stroke within the past 3 months platelet count <100 x 10 9/L prothrombin time > 1.5 times control hematocrit <25% or hemoglobin level <100 g/L alcohol or drug abuse enrolment in other investigational drug trials within the previous month use of thienopyridines, glycoprotein (GP) IIb/IIIa inhibitors, warfarin or acenocoumarol within the previous week allergic reaction or any contraindication to clopidogrel or aspirin administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: 1<br>Clopidogrel 300 mg the day before PCI | Drug: Clopidogrel<br>* clopidogrel 300 mg on the day prior to angiography<br>|
| Experimental: 2<br>Clopidogrel 600 mg the day before PCI | Drug: Clopidogrel<br>* clopidogrel 600 mg on the day prior to angiography<br>|
| Experimental: 3<br>300 mg followed by 75 mg daily started one week prior to angiography | Drug: Clopidogrel<br>* clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography<br>|
| Experimental: 4<br>300 mg followed by 150 mg daily started one week prior to angiography | Drug: Clopidogrel<br>* clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angioplasty, clopidogrel, coronary artery disease, platelets, Percutaneous coronary intervention