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

Coronary Artery Disease Clinical Trial

Official title:

Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693069
• Other study ID #: C.E.2004-06-24A
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2008
• Last updated: August 20, 2012
• Start date: September 2004
• Est. completion date: April 2006

Study information

• Verified date: June 2008
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes