Relationship Between Dosage of Clopidogrel and Platelet Aggregation in Chinese With Different Genotype
RDPAC
1 other identifier
observational
880
1 country
1
Brief 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.
Trial Health
Trial Health Score
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedMay 20, 2013
May 1, 2013
1.1 years
October 15, 2012
May 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in platelet aggregation
1 month and 6 months after PCI
Secondary Outcomes (1)
Major adverse cardiovascular events (MACE); Bleeding events
6 months after PCI
Study Arms (4)
Low dose - Wild genotype (LW)
75mg Qd \> 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 wild genotype
Low dose - Variant genotype (LV)
75mg Qd \> 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 variant genotype
High dose - Wild genotype (HW)
300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 wild genotype
High dose - Variant genotype (HV)
300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 variant genotype
Eligibility Criteria
Chinese coronary heart disease (CHD) patient
You may qualify if:
- accept PCI in Chinese CHD patients
- expected dual antiplatelet therapy (DAPT) at least 6 months
You may not qualify if:
- another planned PCI within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC
Beijing, 100037, China
Related Publications (1)
Zhang X, Yan L, Wang D, Li Y, Han L, Tian L, Liu H, Li Y. Comparison of loading with maintenance dose of clopidogrel on platelet reactivity in Chinese with different CYP2C19 genotypes prior to percutaneous coronary intervention. Chin Med J (Engl). 2014;127(14):2571-7.
PMID: 25043069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 19, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2013
Last Updated
May 20, 2013
Record last verified: 2013-05