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CompletedNCT00693069Updated Aug 21, 2012

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

A Phase 3 interventional study of Clopidogrel and Clopidogrel in Coronary Artery Disease, sponsored by Hopital du Sacre-Coeur de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-08-21.

Sponsored by Hopital du Sacre-Coeur de Montreal · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • angioplasty
  • clopidogrel
  • coronary artery disease
  • platelets
  • Percutaneous coronary intervention
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 120 is close to the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Hopital du Sacre-Coeur de Montreal is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patient with an indication for elective coronary angiography with or without PCI

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    1

    Clopidogrel 300 mg the day before PCI

    Drug: Clopidogrel

  • Experimental
    2

    Clopidogrel 600 mg the day before PCI

    Drug: Clopidogrel

  • Experimental
    3

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

    Drug: Clopidogrel

  • Experimental
    4

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

    Drug: Clopidogrel

Interventions

  • DrugClopidogrel

    clopidogrel 300 mg on the day prior to angiography

  • DrugClopidogrel

    clopidogrel 600 mg on the day prior to angiography

  • DrugClopidogrel

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

  • DrugClopidogrel

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

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 site
  • Hopital du Sacre-Coeur de Montreal
    Montreal, Quebec H4J 1C5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00693069
Lead sponsor
Hopital du Sacre-Coeur de Montreal
First posted
Jun 6, 2008
Start date
Sep 2004
Completion
Apr 2006
Last update
Aug 21, 2012

Study contacts

Jean G Diodati, MD
principal investigator · Hopital du Sacre-Coeur de Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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