Pharmacogenetics of Acenocoumarol
Completed
- Conditions
- Thromboembolic Diseases
- Registration Number
- NCT01492777
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).
The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria
- Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)
- Age ≥ 18 years
- Signed informed consent
Exclusion Criteria
- Severe cognitive impairment
- Previous or current treatment with any coumarin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to achieve stable dosing in days, since the beginning of the anticoagulation 5 weeks
- Secondary Outcome Measures
Name Time Method Mean daily dosage of acenocoumarol 5 weeks Time to achieve two consecutive therapeutic INRs 5 weeks Number of patients with INR > or = 4.0, which indicates overanticoagulation 5 weeks Major bleedings and minor bleedings 5 weeks Thromboembolic events due to infratherapeutic anticoagulation 5 weeks Length of hospitalisation in days 5 weeks Potential of other drug interactions, linked to the observed genotype and phenotype of the patient 5 weeks
Trial Locations
- Locations (1)
University Hospitals
🇨🇭Geneva 14, Switzerland