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Influence of genetic changes of an enzyme (CYP2C19) on a common drug (clopidogrel) treatment in patients with cardiovascular disease

Influence of genetic polymorphism of CYP2C19 on pharmacokinetics and pharmacodynamics of clopidogrel therapy in Indian population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/09/003954
Enrollment
120
Registered
2013-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with cardiovascular disease

Interventions

Intervention1: Clopidogrel: Since this study is planned as an observational study, the dosage of clopidogrel will not be manipulated for this study purpose. The patients will receive Clopidogrel thera

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Clinically unstable patients 2. Patients who are already stabilized with clopidogrel monotherapy or combination therapy with aspirin

Design outcomes

Primary

MeasureTime frame
1. Percentage of the study population with genetic polymorphism of CYP2C19. 2. Percentage of the study population that is resistant to clopidogrel therapy. 3. Association between genetic polymorphism of CYP2C19 and clopidogrel resistance. Timepoint: Sampling time: Pre dose ( 0 day), Post dose - day 1, day 7-14 and day 25

Secondary

MeasureTime frame
1. Level of drug (clopidogrel) and its metabolite in blood samples. 2. Relation between clopidogrel levels and Platelet aggregation in relation to CYP 3A4, CYP2C9 and P2Y12 polymorphism Timepoint: Sampling Time: Two or three samples post oral dosing

Countries

India

Contacts

Public ContactDr M Surulivelrajan

Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, Manipal University

mkunnikrishnan@gmail.com0820-2922482

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026