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

Sponsor:	University of Montreal
Collaborator:	Hopital du Sacre-Coeur de Montreal
Information provided by:	University of Montreal
ClinicalTrials.gov Identifier:	NCT00693069

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by University of 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
1: Active Comparator Clopidogrel 300 mg the day before PCI	Drug: Clopidogrel clopidogrel 300 mg on the day prior to angiography
2: Experimental Clopidogrel 600 mg the day before PCI	Drug: Clopidogrel clopidogrel 600 mg on the day prior to angiography
3: Experimental 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
4: Experimental 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

University of Montreal

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:	Hopital du Sacre-Coeur de Montreal ( Jean G Diodati, MD )
Study ID Numbers:	C.E.2004-06-24A
Study First Received:	June 3, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00693069 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Montreal:

angioplasty
clopidogrel
coronary artery disease
platelets
Percutaneous coronary intervention

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Ticlopidine
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents

Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Fibrin Modulating Agents
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 20, 2009