Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function
Information source: University of Montreal
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Clopidogrel (Drug); Clopidogrel (Drug); Clopidogrel (Drug); Clopidogrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Montreal Official(s) and/or principal investigator(s):
Jean G Diodati, MD, Principal Investigator, Affiliation: Hopital du Sacre-Coeur de Montreal
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.
Clinical Details
Official title: Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Primary outcome: 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.
Secondary outcome: A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Hopital du Sacre-Coeur de Montreal, Montreal, Quebec H4J 1C5, Canada
Additional Information
Starting date: September 2004
Ending date: April 2006
Last updated: June 5, 2008
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