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

This study has been completed.
Sponsor:
Information provided by:
Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT00693069
First received: June 3, 2008
Last updated: August 20, 2012
Last verified: June 2008

June 3, 2008
August 20, 2012
September 2004
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00693069 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • Active Comparator: 1
    Clopidogrel 300 mg the day before PCI
    Intervention: Drug: Clopidogrel
  • Experimental: 2
    Clopidogrel 600 mg the day before PCI
    Intervention: Drug: Clopidogrel
  • Experimental: 3
    300 mg followed by 75 mg daily started one week prior to angiography
    Intervention: Drug: Clopidogrel
  • Experimental: 4
    300 mg followed by 150 mg daily started one week prior to angiography
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2006
Not Provided

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00693069
C.E.2004-06-24A
No
Jean G Diodati, MD, Hopital du Sacre-Coeur de Montreal
Hopital du Sacre-Coeur de Montreal
Not Provided
Principal Investigator: Jean G Diodati, MD Hopital du Sacre-Coeur de Montreal
Hopital du Sacre-Coeur de Montreal
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP