Pharmacogenetics of Acenocoumarol

NCT ID: NCT01492777

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thromboembolic Diseases

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Jules Desmeules

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jules A Desmeules, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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Gschwind L, Rollason V, Boehlen F, Rebsamen M, Combescure C, Matthey A, Bonnabry P, Dayer P, Desmeules JA. P-glycoprotein: a clue to vitamin K antagonist stabilization. Pharmacogenomics. 2015 Jan;16(2):129-36. doi: 10.2217/pgs.14.164.

Reference Type DERIVED
PMID: 25616099 (View on PubMed)

Other Identifiers

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CER 08-019

Identifier Type: -

Identifier Source: org_study_id

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