Tailored anticoagulant treatment for venous thromboembolism prevention

Leiden Thrombosis Recurrence Risk Prevention: Tailored Treatment After a First Venous Thromboembolism

This study is testing how long people who have had a blood clot should take blood-thinning medication to prevent future clots and bleeding.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 608 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 19 sites (Leiden, South-Holland and 18 other locations)
• Trial ID: NCT06087952 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the optimal duration of long-term anticoagulant treatment for patients who have experienced a first venous thromboembolism (VTE). Participants will undergo individualized risk assessments for recurrent VTE and major bleeding through questionnaires and buccal swabs. Based on these assessments, treatment recommendations will be made, and some patients will be randomized to either continue or discontinue anticoagulant therapy after an initial three-month period. The study will follow participants for at least two years to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with a first symptomatic deep vein thrombosis or pulmonary embolism requiring anticoagulant therapy.

Not a fit: Patients with active cancer or those requiring ongoing anticoagulant treatment for other medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized anticoagulant treatment plans, reducing the risk of recurrence while minimizing the risk of major bleeding.

How similar studies have performed: Other studies have explored individualized anticoagulant treatment approaches, but this specific combination of risk assessments and tailored treatment duration is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.
2. 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.
3. Be aged 18 years or above.

Exclusion Criteria:

1. 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
2. Patients who need to continue anticoagulant treatment for another indication (e.g. atrial fibrillation).
3. Patients with a strong indication for long-term antiplatelet therapy despite oral anticoagulation (e.g. those with recent STEMI)
4. Patients with COVID-19 associated VTE (hospital admission because of COVID-19 \<3 months before the VTE) or vaccine-induced immune thrombotic thrombocytopenia (VITT)
5. 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.

Where this trial is running

Leiden, South-Holland and 18 other locations

• Leiden University Medical Center — Leiden, South-Holland, Netherlands (Recruiting)
• Amsterdam Medical Center, location AMC — Amsterdam, Netherlands (Recruiting)
• Wilhelmina Ziekenhuis — Assen, Netherlands (Recruiting)
• Rode Kruis Ziekenhuis — Beverwijk, Netherlands (Recruiting)
• Amphia Ziekenhuis — Breda, Netherlands (Recruiting)
• Haaglanden Medisch Centrum — Den Haag, Netherlands (Recruiting)
• HagaZiekenhuis — Den Haag, Netherlands (Recruiting)
• Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
• Nij Smellinghe Ziekenhuis — Drachten, Netherlands (Recruiting)
• Ziekenhuis Gelderse Vallei — Ede, Netherlands (Recruiting)
• Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
• Admiraal de Ruyter Ziekenhuis — Goes, Netherlands (Recruiting)
• Groene Hart Ziekenhuis — Gouda, Netherlands (Recruiting)
• Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
• University Medical Center Groningen — Groningen, Netherlands (Recruiting)
• Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
• Ikazia Ziekenhuis — Rotterdam, Netherlands (Recruiting)
• Diakonessenhuis — Utrecht, Netherlands (Recruiting)
• Isala Klinieken — Zwolle, Netherlands (Recruiting)

Study contacts

• Principal investigator: Suzanne Cannegieter, MD, PhD — Leiden University Medical Center
• Study coordinator: Suzanne Cannegieter, MD, PhD

Conditions Venous Thromboembolism; Venous Thromboses; Pulmonary Embolism; Deep Vein Thrombosis