Leiden Thrombosis Recurrence Risk Prevention
NCT06087952 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 608
Last updated 2026-02-20
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.
Conditions
- Venous Thromboembolism
- Venous Thromboses
- Pulmonary Embolism
- Deep Vein Thrombosis
Interventions
- OTHER
-
Randomised treatment advice (discontinue vs continue after 3 months)
Randomisation to continue or discontinue anticoagulant therapy in 1:1 ratio stratified on risk category of L-TRRiP and VTE-BLEED score
- DIAGNOSTIC_TEST
-
VTE-BLEED score
Predict bleeding risk during extended anticoagulant treatment (high or low) using the VTE-BLEED score
- DIAGNOSTIC_TEST
-
L-TRRiP score
Predict VTE recurrence risk after anticoagulant discontinuation (high, intermediate or low) using the L-TRRiP score
- OTHER
-
Advise to continue anticoagulant treatment after 3 months
Advise to continue anticoagulant treatment after 3 months for patients with high VTE recurrence and low bleeding risk
- OTHER
-
Advise to discontinue anticoagulant treatment after 3 months
Advise to discontinue anticoagulant treatment after 3 months for patients with low VTE recurrence risk
Sponsors & Collaborators
-
Leiden University Medical Center
lead OTHER
Principal Investigators
-
Suzanne Cannegieter, MD, PhD · Leiden University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-18
- Primary Completion
- 2027-06-01
- Completion
- 2027-06-01
Countries
- Netherlands
Study Locations
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