Thromboembolic Diseases Clinical Trial
Official title:
Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions
| Verified date | June 2013 |
| Source | University Hospital, Geneva |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 115 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospitals | Geneva 14 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Geneva |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to achieve stable dosing in days, since the beginning of the anticoagulation | 5 weeks | No | |
| Secondary | Number of patients with INR > or = 4.0, which indicates overanticoagulation | 5 weeks | No | |
| Secondary | Time to achieve two consecutive therapeutic INRs | 5 weeks | No | |
| Secondary | Mean daily dosage of acenocoumarol | 5 weeks | No | |
| Secondary | Major bleedings and minor bleedings | 5 weeks | No | |
| Secondary | Thromboembolic events due to infratherapeutic anticoagulation | 5 weeks | No | |
| Secondary | Length of hospitalisation in days | 5 weeks | No | |
| Secondary | Potential of other drug interactions, linked to the observed genotype and phenotype of the patient | 5 weeks | No |