Pharmacogenetics of Acenocoumarol
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Geneva
Information provided by (Responsible Party):
Jules Desmeules, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01492777
First received: December 13, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
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Purpose
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.
| Condition |
|---|
|
Thromboembolic Diseases |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions |
Resource links provided by NLM:
Further study details as provided by University Hospital, Geneva:
Primary Outcome Measures:
- Time to achieve stable dosing in days, since the beginning of the anticoagulation [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of patients with INR > or = 4.0, which indicates overanticoagulation [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Time to achieve two consecutive therapeutic INRs [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Mean daily dosage of acenocoumarol [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Major bleedings and minor bleedings [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Thromboembolic events due to infratherapeutic anticoagulation [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Length of hospitalisation in days [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Potential of other drug interactions, linked to the observed genotype and phenotype of the patient [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood samples
| Enrollment: | 115 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Hospitalized patients starting acenocoumarol therapy
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jules Desmeules, Prof, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT01492777 History of Changes |
| Other Study ID Numbers: | CER 08-019 |
| Study First Received: | December 13, 2011 |
| Last Updated: | December 13, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
Acenocoumarol Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013