Influence of genetic changes of an enzyme (CYP2C19) on a common drug (clopidogrel) treatment in patients with cardiovascular disease
Not Applicable
- Conditions
- Health Condition 1: null- Patients with cardiovascular disease
- Registration Number
- CTRI/2013/09/003954
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Patients who are diagnosed with cardiovascular indications requiring treatment with clopidogrel as anti-platelet therapy.
2. Patients who are newly started on clopidogrel therapy and will be visiting cardiology department for follow-up.
Exclusion Criteria
1.Clinically unstable patients
2.Patients who are already stabilized with clopidogrel monotherapy or combination therapy with aspirin
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Percentage of the study population with genetic polymorphism of CYP2C19. <br/ ><br> <br/ ><br>2.Percentage of the study population that is resistant to clopidogrel therapy. <br/ ><br> <br/ ><br>3.Association between genetic polymorphism of CYP2C19 and clopidogrel resistance. <br/ ><br>Timepoint: Sampling time: Pre dose ( 0 day), Post dose - day 1, day 7-14 and day 25
- Secondary Outcome Measures
Name Time Method 1. Level of drug (clopidogrel) and its metabolite in blood samples. <br/ ><br>2. Relation between clopidogrel levels and Platelet aggregation in relation to CYP 3A4, CYP2C9 and P2Y12 polymorphism <br/ ><br>Timepoint: Sampling Time: Two or three samples post oral dosing