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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03914053
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease
Thromboembolism

Detailed 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.


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Study Type : Observational
Actual Enrollment : 3387 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione




Primary Outcome Measures :
  1. time spent in the therapeutic range (TTR) [ Time Frame: 1 day ]
    calculating their time spent in the therapeutic range (TTR).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Probability Sample
Study Population
Patient treated with VKA
Criteria

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

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): NCT03914053


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Emile Emile University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03914053     History of Changes
Other Study ID Numbers: RECHMPL17_0238
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamin K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs