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

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Secondary Outcomes

A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization.

Time frame: 30 days