ThromboembolismVKANCT03914053
Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine
An observational study of Thromboembolism, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thromboembolism
- How many people
- 3,387 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: Patient treated with VKA
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Thromboembolism
- Medical subject headings
- Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
time spent in the therapeutic range (TTR)
calculating their time spent in the therapeutic range (TTR).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 Jul 2017
- Primary completion1 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emile Emile, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914053
- Sponsor's protocol ID
- RECHMPL17_0238
- Acronym
- VKA
- Status last verified
- Jul 2017
- First submitted
- 9 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03914053
- Acronym / sponsor ID
- VKA / RECHMPL17_0238
- Conditions
- Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,387 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patient treated with VKA
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time spent in the therapeutic range (TTR)
Time frame: 1 day
calculating their time spent in the therapeutic range (TTR).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emile Emile principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time spent in the therapeutic range (TTR) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.