Active — Not RecruitingNot Applicable

Leiden Thrombosis Recurrence Risk Prevention

Netherlands608 participantsStarted 2021-06-18

Plain-language summary

The goal of this clinical trial is to evaluate tailored duration of long-term anticoagulant treatment after a first venous thromboembolism based on individualized risk assessments of recurrent VTE and major bleeding risks. Participants will be asked to fill in a questionnaire and take a buccal swab, which are used for an individual estimation of the risks of recurrent VTE and bleeding. Based on these risks a treatment advise will be made, or randomised in a subgroup of patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Provision of informed consent prior to any study specific procedures.
✓. Be diagnosed with a first confirmed symptomatic deep vein thrombosis (including distal vein thrombosis, in Dutch: 'kuitvenetrombose') or pulmonary embolism with an indication for treatment with anticoagulant therapy for at least 3 months as prescribed by their treating physician.
✓. Be aged 18 years or above.

Exclusion criteria

✕. Patients with active cancer (i.e. cancer diagnosis within six months before VTE (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before the venous thromboembolism was diagnosed) or antiphospholipid syndrome
✕. Patients who need to continue anticoagulant treatment for another indication (e.g. atrial fibrillation).
✕. Patients with a strong indication for long-term antiplatelet therapy despite oral anticoagulation (e.g. those with recent STEMI)
✕. Patients with COVID-19 associated VTE (hospital admission because of COVID-19 \<3 months before the VTE) or vaccine-induced immune thrombotic thrombocytopenia (VITT)
✕. Patients in whom the risk of bleeding is deemed extremely high by the treating physician, necessitating discontinuation of anticoagulant treatment for the first VTE after the initial 3 months or even during the initial 3 months.

What they're measuring

Recurrent VTE and major bleeding

Timeframe: 2 years

Trial details

NCT IDNCT06087952

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

View on ClinicalTrials.gov More Venous Thromboembolism trials