Pharmacogenetics of Acenocoumarol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jules Desmeules, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01492777
First received: December 13, 2011
Last updated: June 20, 2013
Last verified: June 2013
  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
Study Completion Date: March 2012
Primary Completion Date: March 2011 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01492777

Locations
Switzerland
University Hospitals
Geneva 14, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Jules A Desmeules, Prof University Hospital, Geneva
  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: June 20, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Acenocoumarol
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014