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

NCT ID: NCT00693069

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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angioplasty clopidogrel coronary artery disease platelets Percutaneous coronary intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Clopidogrel 300 mg the day before PCI

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

clopidogrel 300 mg on the day prior to angiography

2

Clopidogrel 600 mg the day before PCI

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

clopidogrel 600 mg on the day prior to angiography

3

300 mg followed by 75 mg daily started one week prior to angiography

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography

4

300 mg followed by 150 mg daily started one week prior to angiography

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography

Interventions

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Clopidogrel

clopidogrel 300 mg on the day prior to angiography

Intervention Type DRUG

Clopidogrel

clopidogrel 600 mg on the day prior to angiography

Intervention Type DRUG

Clopidogrel

clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography

Intervention Type DRUG

Clopidogrel

clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role lead

Responsible Party

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Hopital du Sacre-Coeur de Montreal

Principal Investigators

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Jean G Diodati, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Locations

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Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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C.E.2004-06-24A

Identifier Type: -

Identifier Source: org_study_id