Pharmacogenetics of Acenocoumarol | NCT01492777

Studies
Pharmacogenetics of Acenocoumarol

NCT01492777

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Jun 21, 2013Estimated

Enrollment

115Actual

Phase

Not provided

Conditions

Thromboembolic Diseases

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 13, 2011

First Posted Date

Dec 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2013

Last Update Posted Date

Jun 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

115Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with INR > or = 4.0, which indicates overanticoagulation		5 weeks
Time to achieve two consecutive therapeutic INRs		5 weeks
Mean daily dosage of acenocoumarol

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospitalized patients starting acenocoumarol therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jules A Desmeules, Prof	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals		Geneva		1211	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25616099	Derived	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.