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

Thromboembolism Clinical Trial

— VKA  

Official title:

Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine : Study ok Variables Influencing the Time Paid in the Therapeutic Target

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914053
• Other study ID #: RECHMPL17_0238
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3387
• Est. completion date: December 31, 2018
• Est. primary completion date: September 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time spent in the therapeutic range (TTR)	calculating their time spent in the therapeutic range (TTR).	1 day