Clopidogrel Pharmacogenetic Score System
CPASS
1 other identifier
observational
500
1 country
2
Brief Summary
The aim of the present study is to evaluate candidate variables,including Cytochrome P450 2C19(CYP2C19) genotypes, clinical and demographic variables,to establish a simple risk score that can be easily adopted by clinicians to identify patients who are at risk for HPR and composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedNovember 25, 2013
November 1, 2013
1 year
November 18, 2013
November 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
high on-treatment platelet reactivity (HPR)
A threshold of 50% maximal post-procedural aggregation was chosen to define HPR.
After 30 days maintenance dose of clopidogrel administration
Secondary Outcomes (2)
Composite ischemia cardiovascular outcomes
1 year
Hemorrhagic complications
1 year
Study Arms (1)
Clopidogrel treated patients
A consecutive cohort with 500 cases treated with 75mg/day maintenance dose of clopidogrel.
Eligibility Criteria
consecutive patients treated with maintenance dose of clopidogrel
You may qualify if:
- Patients more than 18 years old
- 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
You may not qualify if:
- Known contraindication to dual anti-platelet therapy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institute of Geriatric Cardiology, General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100853, China
Institute of Geriatric Cardiology
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
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.
PMID: 23726091BACKGROUND
Biospecimen
DNA extracted from peripheral whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tong Yin, Dr.
Institute of Geriatric Cardiology, General Hospital of People's Liberation Army, Beijing China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate of Institute of Geriatric Cardiology
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 25, 2013
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
November 25, 2013
Record last verified: 2013-11