Study Results
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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UNKNOWN
500 participants
OBSERVATIONAL
2014-01-31
2015-01-31
Brief Summary
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Detailed Description
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Study objectives:
The present study aims to evaluate candidate variables,including CYP2C19 gene polymorphisms, clinical and demographic variables,to establish a simple risk score to identify patients who are at risk for HPR and composite cardiovascular outcomes .
Study design:
Step 1: Population enrollment and medication This mono-center study will be conducted in General Hospital of Chinese People's Liberation Army. Consecutive patients more than 18 years old admitted for ACS will be recruited after giving informed consents. After admission, all enrolled patients will be treated with 100 mg aspirin and 75mg clopidogrel per day. A loading dose of 300 mg clopidogrel will be given to patients undergoing coronary angiography.
Step 2: Clinical and demographic data collection A detailed demographic and medical data will be extracted from medical charts and prescription records. For the development of the risk score system, we will chose variables that are available in routine clinical practice. Clinical candidate variables include smoking history, diabetes,hypertension, renal failure with a serum creatinine\>1.5mg/dL-1, hypercholesterolemia, left ventricular dysfunction, age, gender, acute coronary syndrome on admission and co-medication with statins, calcium channel inhibitor, and proton pump inhibitors.
Step 3 : Platelet function measurements and Genotyping After 5 days maintenance dose of clopidogrel administration, blood samples will be drawn for light transmittance aggregometry (LTA) testing, using an APACT-4 aggregometer (LABiTec, Germany). The magnitude of on-treatment platelet reactivity was quantified using LTA with 20µmol/L ADP(adenosine disphosphate) as the agonist. Aggregation was expressed as the maximal percentage change in light transmittance from baseline, with platelet-poor plasma as the reference.
Genomic DNA will be extracted from the peripheral blood leucocytes of each patient. The loss of function alleles, CYP2C19\*2 (rs4244285) and CYP2C19\*3 (rs4986893), will be genotyped by the polymerase chain reaction(PCR)-ligase detection reactions(LDR)sequencing method.
Step 4: Follow-up At one year, the incidence of composite cardiovascular outcomes will be assessed by review of the patients'charts on re-admission or by telephone interview. Telephone interviewers are blinded with respect to the results of platelet aggregation and genotypes.
Step 5: Statistical analysis and development of risk score Logistic regression and Cox proportional hazards survival regression will be used to develop the risk score system with the candidate variables including clinical and demographic variables, CYP2C19 genotypes, and platelet aggregation.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Clopidogrel treated patients
A consecutive cohort with 500 cases treated with 75mg/day maintenance dose of clopidogrel.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admitted for ACS to the Department of Geriatric Cardiology, General Hospital of Chinese People's Liberation Army
* The diagnosis of ACS according to the American Heart Association/American College of Cardiology (AHA/ACC) criteria, 2012
Exclusion Criteria
* History of chronic inflammatory disease
* Steroidal and non-steroidal anti-inflammatory drugs use
* Previous administration of antiplatelet drugs within 1 month before coronary artery angiography
* Illicit drug abuse
* Significant bleeding tendency
* Cerebrovascular events within 3months
* Major surgery within 4 weeks
18 Years
85 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Tong Yin
Research Associate of Institute of Geriatric Cardiology
Principal Investigators
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Tong Yin, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Geriatric Cardiology, General Hospital of People's Liberation Army, Beijing China
Locations
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Institute of Geriatric Cardiology, General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Institute of Geriatric Cardiology
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Tong Yin, Doctor
Role: primary
Tong Yin, Dr.
Role: primary
References
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Zhang L, Chen Y, Jin Y, Qu F, Li J, Ma C, Yang J, Xu B, Wang H, Li X, Li Y, Zhang Y, Lu C, Yin T. Genetic determinants of high on-treatment platelet reactivity in clopidogrel treated Chinese patients. Thromb Res. 2013 Jul;132(1):81-7. doi: 10.1016/j.thromres.2013.05.006. Epub 2013 May 29.
Other Identifiers
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2012042
Identifier Type: -
Identifier Source: org_study_id