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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital du Sacre-Coeur de Montreal
• Treatments: Clopidogrel; Ticlopidine

Criteria

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