Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine

NCT ID: NCT03914053

Last Updated: 2019-04-12

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

3387 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-31

Brief Summary

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Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

Detailed Description

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Despite the rise in prescriptions for direct oral anticoagulants, Vitamin K antagonists (VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

The management of VKA in France seems hardly comparable to that of the neighboring countries in front of:

* A TTR estimated at 60%.
* Majority management of anticoagulant treatments by general practitioners.
* The weak development of clinics anticoagulants.
* The takeoff of direct oral anticoagulant prescriptions.
* Preponderance of fluindione prescriptions among the various oral anticoagulants.

It therefore seems interesting to study a cohort of French patients under VKA. Through the calculation of the TTR, the investigators will be able to draw a picture of the balance of the anticoagulant treatment and try to identify factors that can influence it.

Conditions

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Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient treated with VKA.
* Realization of INR in one of the labs of the territory of LaboSud Oc biology between 1 September 2015 and 13 January 2016.

Exclusion Criteria

* Less than 3 INR during the data collection period (TTR calculation not possible).
* Time greater than 56 days between two INRs (calculation of the invalid TTR).
* Interrupted treatment (calculation of invalid TTR).
* Lack of information about the patient
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emile Emile

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL17_0238

Identifier Type: -

Identifier Source: org_study_id

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