Pharmacogenetics of Acenocoumarol

June 20, 2013 updated by: Jules Desmeules, University Hospital, Geneva

Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva 14, Switzerland, 1211
        • University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients starting acenocoumarol therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to achieve stable dosing in days, since the beginning of the anticoagulation
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with INR > or = 4.0, which indicates overanticoagulation
Time Frame: 5 weeks
5 weeks
Time to achieve two consecutive therapeutic INRs
Time Frame: 5 weeks
5 weeks
Mean daily dosage of acenocoumarol
Time Frame: 5 weeks
5 weeks
Major bleedings and minor bleedings
Time Frame: 5 weeks
5 weeks
Thromboembolic events due to infratherapeutic anticoagulation
Time Frame: 5 weeks
5 weeks
Length of hospitalisation in days
Time Frame: 5 weeks
5 weeks
Potential of other drug interactions, linked to the observed genotype and phenotype of the patient
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Jules A Desmeules, Prof, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 08-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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