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OpenTrials
Completed

NCT Number: NCT01492777

Pharmacogenetics of Acenocoumarol

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.

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Key information

Conditions

Thromboembolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to achieve stable dosing in days, since the beginning of the anticoagulation

    Time frame: 5 weeks

Secondary outcomes

  1. Number of patients with INR > or = 4.0, which indicates overanticoagulation

    Time frame: 5 weeks

  2. Time to achieve two consecutive therapeutic INRs

    Time frame: 5 weeks

  3. Mean daily dosage of acenocoumarol

    Time frame: 5 weeks

  4. Major bleedings and minor bleedings

    Time frame: 5 weeks

  5. Thromboembolic events due to infratherapeutic anticoagulation

    Time frame: 5 weeks

  6. Length of hospitalisation in days

    Time frame: 5 weeks

  7. Potential of other drug interactions, linked to the observed genotype and phenotype of the patient

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Dec 15, 2011
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.