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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Clopidogrel; Drug: Clopidogrel; Drug: Clopidogrel; Drug: Clopidogrel

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital du Sacre-Coeur de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Clopidogrel 300 mg the day before PCI	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
Experimental: 2; Clopidogrel 600 mg the day before PCI	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
Experimental: 3; 300 mg followed by 75 mg daily started one week prior to angiography	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
Experimental: 4; 300 mg followed by 150 mg daily started one week prior to angiography	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hopital du Sacre-Coeur de Montreal

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: June 5, 2008
• First Posted (Estimate): June 6, 2008

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: coronary artery disease; Percutaneous coronary intervention; clopidogrel; platelets; angioplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: C.E.2004-06-24A