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Pharmacogenetics of Acenocoumarol

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ClinicalTrials.gov Identifier: NCT01492777
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Thromboembolic Diseases

Study Design

Study Type : Observational
Actual Enrollment : 115 participants
Time Perspective: Prospective
Official Title: Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions
Study Start Date : November 2008
Primary Completion Date : March 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Time to achieve stable dosing in days, since the beginning of the anticoagulation [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Whole blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jules Desmeules, Prof, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01492777     History of Changes
Other Study ID Numbers: CER 08-019
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Acenocoumarol
Anticoagulants