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

Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00693069

Enrollment

120

Registered

2008-06-06

Start date

2004-09-30

Completion date

2006-04-30

Last updated

2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

angioplasty, clopidogrel, coronary artery disease, platelets, Percutaneous coronary intervention

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.

Interventions

DRUGClopidogrel

clopidogrel 300 mg on the day prior to angiography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026