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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:
ClinicalTrials.gov Identifier:
NCT00693069
First Posted: June 6, 2008
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hopital du Sacre-Coeur de Montreal
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 3, 2008
First Posted: June 6, 2008
Last Update Posted: August 21, 2012
Last Verified: June 2008

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
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
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors


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