NCT00693069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

August 21, 2012

Status Verified

June 1, 2008

First QC Date

June 3, 2008

Last Update Submit

August 20, 2012

Conditions

Coronary Artery Disease

Keywords

angioplastyclopidogrelcoronary artery diseaseplateletsPercutaneous coronary intervention

Outcome Measures

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.

    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.

    30 days

Study Arms (4)

1

ACTIVE COMPARATOR

Clopidogrel 300 mg the day before PCI

Drug: Clopidogrel

2

EXPERIMENTAL

Clopidogrel 600 mg the day before PCI

Drug: Clopidogrel

3

EXPERIMENTAL

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

Drug: Clopidogrel

4

EXPERIMENTAL

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

Drug: Clopidogrel

Interventions

ClopidogrelDRUG

clopidogrel 300 mg on the day prior to angiography

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jean G Diodati, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

September 1, 2004

Study Completion

April 1, 2006

Last Updated

August 21, 2012

Record last verified: 2008-06

Locations

CA(1)