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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel
Clopidogrel
Clopidogrel
Sponsored by
Hopital du Sacre-Coeur de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring angioplasty, clopidogrel, coronary artery disease, platelets, Percutaneous coronary intervention

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital du Sacre-Coeur de Montreal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Clopidogrel 300 mg the day before PCI

Clopidogrel 600 mg the day before PCI

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

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

Outcomes

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.

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.

Full Information

First Posted
June 3, 2008
Last Updated
August 20, 2012
Sponsor
Hopital du Sacre-Coeur de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT00693069
Brief Title
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function
Official Title
Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hopital du Sacre-Coeur de Montreal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
angioplasty, clopidogrel, coronary artery disease, platelets, Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Clopidogrel 300 mg the day before PCI
Arm Title
2
Arm Type
Experimental
Arm Description
Clopidogrel 600 mg the day before PCI
Arm Title
3
Arm Type
Experimental
Arm Description
300 mg followed by 75 mg daily started one week prior to angiography
Arm Title
4
Arm Type
Experimental
Arm Description
300 mg followed by 150 mg daily started one week prior to angiography
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
clopidogrel 300 mg on the day prior to angiography
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
clopidogrel 600 mg on the day prior to angiography
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean G Diodati, MD
Organizational Affiliation
Hopital du Sacre-Coeur de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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