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

NCT ID: NCT01710436

Last Updated: 2013-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

880 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Low dose - Wild genotype (LW)

75mg Qd \> 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 wild genotype

No interventions assigned to this group

Low dose - Variant genotype (LV)

75mg Qd \> 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 variant genotype

No interventions assigned to this group

High dose - Wild genotype (HW)

300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 wild genotype

No interventions assigned to this group

High dose - Variant genotype (HV)

300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 variant genotype

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaoxing Zhang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 25043069 (View on PubMed)

Other Identifiers

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RDPAC2012

Identifier Type: -

Identifier Source: org_study_id

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