Official Title: “Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Pharmacodynamics Study

Intervention(s) in this Clinical Trial

• Drug: Clopidogrel
  • clopidogrel 300 mg on the day prior to angiography
• Drug: Clopidogrel
  • clopidogrel 600 mg on the day prior to angiography
• Drug: Clopidogrel
  • clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography
• Drug: Clopidogrel
  • clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Clopidogrel 300 mg the day before PCI
• Experimental: 2
  • Clopidogrel 600 mg the day before PCI
• Experimental: 3
  • 300 mg followed by 75 mg daily started one week prior to angiography
• Experimental: 4
  • 300 mg followed by 150 mg daily started one week prior to angiography

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Montreal

Overall Clinical Trial Officials and Contacts

Jean G Diodati, MD Principal Investigator Hopital du Sacre-Coeur de Montreal  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693069

Study ID Number: C.E.2004-06-24A

ClinicalTrials.gov Identifier: NCT00693069

Health Authority: Canada: Ethics Review Committee