Coronary Heart Disease Clinical Trial
— RDPACVerified 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 |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences, Fuwai Hospital |
China,
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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