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

Montreal Sacred Heart Hospital

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00693069

C.E.2004-06-24A

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

1

Active Comparator group

Description:

Clopidogrel 300 mg the day before PCI

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

2

Experimental group

Description:

Clopidogrel 600 mg the day before PCI

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

3

Experimental group

Description:

300 mg followed by 75 mg daily started one week prior to angiography

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

4

Experimental group

Description:

300 mg followed by 150 mg daily started one week prior to angiography

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel