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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Clopidogrel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital du Sacre-Coeur de Montreal:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: September 2004
Study Completion Date: April 2006
Arms Assigned Interventions
Active Comparator: 1
Clopidogrel 300 mg the day before PCI
 Drug: Clopidogrel
clopidogrel 300 mg on the day prior to angiography
Experimental: 2
Clopidogrel 600 mg the day before PCI
 Drug: Clopidogrel
clopidogrel 600 mg on the day prior to angiography
Experimental: 3
300 mg followed by 75 mg daily started one week prior to angiography
 Drug: Clopidogrel
clopidogrel 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
 Drug: Clopidogrel
clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693069

Locations
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Investigators
Principal Investigator: Jean G Diodati, MD Hopital du Sacre-Coeur de Montreal
  More Information

No publications provided

Responsible Party: Jean G Diodati, MD, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT00693069     History of Changes
Other Study ID Numbers: C.E.2004-06-24A
Study First Received: June 3, 2008
Last Updated: August 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital du Sacre-Coeur de Montreal:
angioplasty
clopidogrel
coronary artery disease
platelets
Percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013