Overview

This trial is active, not recruiting.

Condition coronary heart disease
Sponsor Cardiovascular Institute & Fuwai Hospital
Start date October 2012
End date November 2013
Trial size 880 participants
Trial identifier NCT01710436, RDPAC2012

Summary

This study is a prospective, observational study to estimate the relationship between dosage of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
75mg Qd > 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 wild genotype
75mg Qd > 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 variant genotype
300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 wild genotype
300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 variant genotype

Primary Outcomes

Measure
Change from Baseline in platelet aggregation
time frame: 1 month and 6 months after PCI

Secondary Outcomes

Measure
Major adverse cardiovascular events (MACE); Bleeding events
time frame: 6 months after PCI

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - accept PCI in Chinese CHD patients - expected dual antiplatelet therapy (DAPT) at least 6 months Exclusion Criteria: - another planned PCI within 6 months

Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Cardiovascular Institute & Fuwai Hospital.