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

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Clopidogrel

• Registration Number: NCT00693069
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2006-04
• Status Verified: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Submitted: 2012-08-20
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult patient with an indication for elective coronary angiography with or without PCI

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Clopidogrel	Clopidogrel 600 mg the day before PCI
1	Clopidogrel	Clopidogrel 300 mg the day before PCI
4	Clopidogrel	300 mg followed by 150 mg daily started one week prior to angiography
3	Clopidogrel	300 mg followed by 75 mg daily started one week prior to angiography

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada