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Improving decision-making for managing unprovoked venous thromboembolism

Prognosis Improvement of Unprovoked vEnous THromboEmbolism With the Use of a Shared Decision-making Process Including a Time-dependent Multicomponent Risk Prediction Scores inteRvention.

Not applicable Interventional University Hospital, Brest · NCT06731244

This study is testing a new way to help patients with unprovoked blood clots decide how long to take blood thinners, to see if it leads to better health outcomes.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2400 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Brest Academic / other
Locations20 sites (Brest, France and 19 other locations)
Trial IDNCT06731244 on ClinicalTrials.gov

What this trial studies

This study focuses on enhancing the management of unprovoked venous thromboembolism (VTE) through a shared decision-making process. It involves patients who have experienced a first episode of symptomatic unprovoked pulmonary embolism or proximal deep vein thrombosis and have been treated with anticoagulants for 3 to 6 months. The study compares usual care with a structured decision-making approach to determine the optimal duration of anticoagulant therapy, addressing the significant risks associated with both VTE and anticoagulation. The goal is to improve patient outcomes by tailoring treatment duration based on individual circumstances.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have had a first episode of symptomatic unprovoked pulmonary embolism or proximal deep vein thrombosis treated with anticoagulants for 3 to 6 months.

Not a fit: Patients with isolated distal DVT, isolated sub-segmental PE, or those with previous unprovoked VTE may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective management of anticoagulant therapy, reducing risks of recurrence and bleeding for patients.

How similar studies have performed: Other studies have explored shared decision-making in healthcare, indicating potential for success, but this specific approach for unprovoked VTE management is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patient \> or = 18 years,
* Patient with a first episode of symptomatic unprovoked pulmonary embolism (PE) and/or proximal deep vein thrombosis (DVT) treated for 3 to 6 uninterrupted months with full dose anticoagulant therapy,
* Signed informed consent.

Exclusion Criteria:

* Unable or refusal to give informed consent,
* Isolated distal DVT,
* Isolated sub-segmental PE
* Previous unprovoked VTE
* Known CTEPH
* Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves…),
* Interruption of anticoagulation for 14 days or more before the inclusion,
* Active cancer of less than 24 months,
* Current pregnancy,
* Life expectancy \<18 months (e.g.; patients with an end-stage chronic disease)
* Not affiliated to national insurance, social security (only for France)

Where this trial is running

Brest, France and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous Thromboembolismvenous thrombosispulmonary embolismAnticoagulantdeep vein thrombosisstepped-wedge cluster randomized trialshared-decision making
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.