Early access
Sign in
Not yet recruitingNo phase

Decision aid for choosing how long to take blood thinners after a blood clot

Tests a decision aid for people deciding whether to continue blood thinners after a clot.

Key facts

Who runs it
McGill University Health Centre/Research Institute of the McGill University Health Centre
Where
Canada5 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism
Status
Not yet recruiting
People taking part
850 people, planned
Started
Sept 2026
Expected to end
Mar 2029
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • DECIDE-VTE Patient Decision Aid
Record updated
24 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a first blood clot in a deep vein or lung with no clear or only a weak cause. They have taken blood thinners for at least 3 months and must decide whether to continue.

Age
18 years or older
Sex
All sexes
Disease stage
First confirmed clot in a large (proximal) deep leg vein and/or a segmental or larger lung clot (pulmonary embolism), with no clear or only a weak cause. Enrolment within 12 months of the diagnosis.
Earlier treatment
At least 3 months of full-dose blood thinner treatment, and still taking it now. No earlier dedicated visit to decide long-term blood thinner use.

Main reasons for not taking part

  • More than one clot with no clear or only a weak cause
  • Clot caused by a strong trigger such as major surgery, major injury, a plaster cast or long bed rest, or a lasting trigger such as active cancer
  • Women at very low risk of another clot (HERDOO2 score 0-1)
  • High bleeding risk, so blood thinners should be stopped
  • Need for long-term blood thinners for another reason, such as atrial fibrillation

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Age 18 years or older
  • First episode of objectively confirmed unprovoked or weakly provoked venous thromboembolism (VTE)
  • Objectively confirmed proximal deep vein thrombosis and/or segmental or greater pulmonary embolism
  • Completed at least 3 months of therapeutic anticoagulation and currently receiving anticoagulation
  • Enrollment within 12 months of diagnosis of the index/qualifying VTE event
  • Able to provide written informed consent
  • Able to participate in shared decision-making in English or French

Who cannot take part

  • Index/qualifying VTE is a strongly provoked VTE (e.g., associated with major surgery, major trauma, plaster cast immobilization, or prolonged bed rest)
  • Prior dedicated long-term anticoagulation Decision Visit regarding anticoagulation duration
  • Index/qualifying VTE associated with a persistent strong provoking risk factor (e.g., active cancer or ongoing immobility)
  • High bleeding risk such that anticoagulation should be discontinued
  • Recurrent unprovoked or weakly provoked VTE I(i.e. multiple unprovoked/weakly provoked VTE)
  • Women at very low recurrence risk (HERDOO2 score 0-1)
  • Requirement for long-term anticoagulation for another indication (e.g., atrial fibrillation)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, is a common condition that is typically treated with blood thinners (anticoagulants). After completing at least 3 months of treatment for a first unprovoked or weakly provoked VTE, patients and clinicians must decide whether to stop anticoagulation or continue treatment for a longer period. Continuing anticoagulation reduces the risk of another blood clot but increases the risk of bleeding. Because both options involve important benefits and risks, this decision should reflect the patient's values and preferences.

Read full original descriptionShow less

The DECIDE-VTE study will evaluate whether a patient decision aid can improve decision-making for patients facing this choice. The decision aid provides evidence-based information about the risks and benefits of continuing versus stopping anticoagulation and includes a values clarification exercise to help patients identify what matters most to them.

This multicentre batched stepped-wedge cluster randomized trial will be conducted in 12 thrombosis clinics across Canada. Clinics will transition from usual care to implementation of the patient decision aid according to a randomized schedule. The primary outcome is decisional conflict immediately following the anticoagulation decision visit, measured using the Decisional Conflict Scale. Secondary outcomes include patient knowledge, treatment decisions, decisional regret, concordance with the chosen treatment strategy, recurrent venous thromboembolism, major bleeding, all-cause mortality, and implementation outcomes.

The 2 groups in the trial

  • Usual CareNo study treatment, for comparison

    Participants receive standard thrombosis clinic care and clinician-patient discussions regarding continuation versus discontinuation of anticoagulation following a first unprovoked or weakly provoked venous thromboembolism. No structured patient decision aid is used.

  • DECIDE-VTE Patient Decision AidTreatment being tested

    Participants receive the DECIDE-VTE Patient Decision Aid in addition to usual thrombosis clinic care. The decision aid provides evidence-based information regarding the risks and benefits of continuing versus discontinuing anticoagulation after a first unprovoked or weakly provoked venous thromboembolism and includes a structured values clarification exercise to support shared decision-making. Participants and clinicians make the final treatment decision together during the Decision Visit.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Enabling and Engaging Patients to Decide Indefinite Versus Short-Term Anticoagulation for Venous Thromboembolism (DECIDE-VTE)
Plain-language title
Decision aid for choosing how long to take blood thinners after a blood clotGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
24 June 2026