Leiden Thrombosis Recurrence Risk Prevention
L-TRRiP
4 other identifiers
interventional
608
1 country
19
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2021
CompletedFirst Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
February 20, 2026
February 1, 2026
6 years
July 25, 2023
February 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrent VTE and major bleeding
Incidence of the combined endpoint recurrent VTE and major bleeding in the randomised arms
2 years
Secondary Outcomes (9)
Primary outcome weighted for quality of life (EQ-5D-5L)
2 years
Primary outcome weighted for functional status (PFVS)
2 years
Cost-effectiveness
Up to 2 years
Recurrent VTE and major bleeding in non-randomised arms
2 years
Clinically relevant non-major bleeding
2 years
- +4 more secondary outcomes
Study Arms (4)
Continue anticoagulation
OTHERPatients with high recurrent VTE risk and low major bleeding risks are advised to continue anticoagulant therapy.
Discontinue anticoagulation
OTHERPatients with low recurrent VTE risk are advised to discontinue anticoagulant therapy.
Randomised to continue anticoagulation
OTHERPatients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy.
Randomised to discontinue anticoagulation
OTHERPatients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy.
Interventions
Randomisation to continue or discontinue anticoagulant therapy in 1:1 ratio stratified on risk category of L-TRRiP and VTE-BLEED score
Predict VTE recurrence risk after anticoagulant discontinuation (high, intermediate or low) using the L-TRRiP score
Predict bleeding risk during extended anticoagulant treatment (high or low) using the VTE-BLEED score
Advise to continue anticoagulant treatment after 3 months for patients with high VTE recurrence and low bleeding risk
Advise to discontinue anticoagulant treatment after 3 months for patients with low VTE recurrence risk
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Leiden University Medical Center
Leiden, South Holland, 2333 ZA, 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
Related Publications (1)
Burggraaf-van Delft JLI, van Rein N, Bemelmans RHH, van den Berg JK, Bruggeman CY, Cloos-van Balen M, Coppens M, Eefting M, Ende-Verhaar Y, van Es N, van Guldener C, de Jong WK, Kleijwegt F, Koster T, Kroon C, Kuipers S, Leentjens J, Luijten D, Mairuhu ATA, Meijer K, van de Ree MA, Roos R, Schrover I, Swart-Heikens J, van der Velden AWG, van den Akker-van Marle EM, le Cessie S, Geersing GJ, Middeldorp S, Huisman MV, Klok FA, Cannegieter SC; L-TRRiP investigators. Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial. BMJ Open. 2024 Mar 23;14(3):e078676. doi: 10.1136/bmjopen-2023-078676.
PMID: 38521524DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Cannegieter, MD, PhD
Leiden University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Blinded endpoint adjudication
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Epidemiology
Study Record Dates
First Submitted
July 25, 2023
First Posted
October 18, 2023
Study Start
June 18, 2021
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
After data collection and data cleaning are finished deidentified data will be registered in a repository and be made available for further research upon reasonable request to the corresponding author.