Improving decision-making for managing unprovoked venous thromboembolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Brest
  Brest, France, France Recruiting
• CHU d'Amiens - Picardie
  Amiens, France Not yet recruiting
• CHU d'Angers
  Angers, France Not yet recruiting
• Hôpital National d'Instruction des Armées Percy
  Clamart, France Not yet recruiting
• CHU de Clermont Ferrand
  Clermont-Ferrand, France Not yet recruiting
• APHP-Colombes
  Colombes, France Not yet recruiting

Study contacts

• Study coordinator: Francis COUTURAUD, Prof.
• Email: francis.couturaud@chu-brest.fr
• Phone: +33298347348

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.