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ACTIVE NOT RECRUITING
NCT06087952
NA

Leiden Thrombosis Recurrence Risk Prevention

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

608

Start Date

2021-06-18

Completion Date

2027-06-01

Last Updated

2026-02-20

Healthy Volunteers

No

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

Locations (19)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Amsterdam Medical Center, location AMC

Amsterdam, Netherlands

Wilhelmina Ziekenhuis

Assen, Netherlands

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

Nij Smellinghe Ziekenhuis

Drachten, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

Groene Hart Ziekenhuis

Gouda, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Ikazia Ziekenhuis

Rotterdam, Netherlands

Haaglanden Medisch Centrum

The Hague, Netherlands

HagaZiekenhuis

The Hague, Netherlands

Diakonessenhuis

Utrecht, Netherlands

Isala Klinieken

Zwolle, Netherlands