Leiden Thrombosis Recurrence Risk Prevention

NCT06087952 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2026-02-20

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087952 on ClinicalTrials.gov