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NCT01710436 Clinical Trial

Relationship Between Dosage of Clopidogrel and Platelet Aggregation in Chinese With Different Genotype

Coronary Heart Disease Clinical Trial

— RDPAC  

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01710436
Other study ID # RDPAC2012
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 15, 2012
Last updated May 16, 2013
Start date October 2012

Study information
Verified date May 2013
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 880
Est. completion date
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in platelet aggregation 1 month and 6 months after PCI No
Secondary Major adverse cardiovascular events (MACE); Bleeding events 6 months after PCI Yes
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