Status:
RECRUITING
Leiden Thrombosis Recurrence Risk Prevention
Lead Sponsor:
Leiden University Medical Center
Conditions:
Venous Thromboembolism
Venous Thromboses
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Background: Patients with a first venous thromboembolism (VTE) are at risk of recurrence. A recurrent VTE can be prevented by prolonged anticoagulant therapy, but this may come at the cost of major bl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
608 Patients enrolled
Trial Details
Trial ID
NCT06087952
Start Date
June 18 2021
End Date
June 1 2027
Last Update
March 7 2025
Active Locations (19)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
2
Amsterdam Medical Center, location AMC
Amsterdam, Netherlands
3
Wilhelmina Ziekenhuis
Assen, Netherlands
4
Rode Kruis Ziekenhuis
Beverwijk, Netherlands