Venous ThromboembolismL-TRRiPNCT06087952
Leiden Thrombosis Recurrence Risk Prevention
A study testing Randomised treatment advice (discontinue vs continue after 3 months), VTE-BLEED score and L-TRRiP score in people with Venous Thromboembolism and Venous Thromboses, run by Leiden University Medical Center at 19 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Venous Thromboses, Pulmonary Embolism
- What is being tested?
- Randomised treatment advice (discontinue vs continue after 3 months), VTE-BLEED score and L-TRRiP score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 19 sitesNetherlands
- Study dates
- 18 Jun 2021to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Netherlands19 sites
Amsterdam Medical Center, location AMC
Amsterdam
Wilhelmina Ziekenhuis
Assen
Rode Kruis Ziekenhuis
Beverwijk
Amphia Ziekenhuis
Breda
Deventer Ziekenhuis
Deventer
Nij Smellinghe Ziekenhuis
Drachten
Ziekenhuis Gelderse Vallei
Ede
Catharina Ziekenhuis
Eindhoven
Admiraal de Ruyter Ziekenhuis
Goes
Groene Hart Ziekenhuis
Gouda
Martini Ziekenhuis
Groningen
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Radboud University Medical Center
Nijmegen
Ikazia Ziekenhuis
Rotterdam
Haaglanden Medisch Centrum
The Hague
HagaZiekenhuis
The Hague
Diakonessenhuis
Utrecht
Isala Klinieken
Zwolle
About this study
Official title: Leiden Thrombosis Recurrence Risk Prevention: Tailored Treatment After a First Venous Thromboembolism
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.
Read the 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 bleeding. The L-TRRiP and VTE-BLEED prediction scores have been developed to classify the risk of recurrent VTE (low, intermediate, high) and major bleeding (low vs high), respectively. However, their combined use in finding the optimal balance to minimize both long-term risks is unclear.
Aims: To evaluate tailored duration of long-term anticoagulant treatment based on individualized risk assessments of recurrent VTE and major bleeding risks.
Methods:
The L-TRRiP study is a multicenter, open-label, cohort based randomized controlled trial in which patients with a first VTE will be included. For each patient the risk of recurrent VTE (low, medium, high) and major bleeding (low, high) will be determined using the L-TRRiP and VTE-BLEED prediction scores, respectively. After three months of initial anticoagulant therapy, patients with a low recurrent VTE risk (<6% in 2 years) will discontinue anticoagulants, whereas patients with a high recurrent VTE risk(>14% in 2 years) and low major bleeding risk will continue. The other groups, with unclear benefit of prolonged treatment, will be randomized to continue or discontinue anticoagulants. Patients will be followed for at least two years, during which they will be asked to fill in a questionnaire every 3 months during the first two years, followed by a questionnaire once a year for the remaining duration of the study (i.e., 2 years after inclusion of the last participant; which is expected to be in 2027). The total follow-up duration is therefore expected to vary between 2 to 6 years. The follow-up questionnaires are used to screen for potential outcomes (including recurrent VTE and bleeding), and includes the EQ-5D-5L to assess quality of life, the Post VTE functional status scale to assess functional outcomes and the Medical Consumption and Productivity Costs Questionnaire to asses cost-effectiveness. In case of a potential outcome additional information is retrieved from the medical record for adjudication. The clinical outcomes will be evaluated and classified by an independent committee blinded for treatment allocation.
Sample size: The sample size of this study is based on the randomized part of the study. To demonstrate a 7% difference in the combined endpoint (i.e., 10.6% vs 3.6%) with an alpha of 0.05 and a power of 90%, a sample size of 552 subjects for the randomized part of the study is required. Taking into account a drop-out rate of 10%, the aim is to include 608 patients in the randomized part of the study. After inclusion of 608 randomized patients, inclusion will stop. Based on the derivation studies it is expected the randomized group will form about 40% of the total included population, in which case the estimated total number of included patients will be 1600. Of note, this total number may change depending on the final proportion of the randomized group.
Ethics: The study has been approved by the Medical Ethics Committee Leiden Den Haag Delft. All participants will provide informed consent.
- Being tested
- Randomised treatment advice (discontinue vs continue after 3 months), VTE-BLEED score, L-TRRiP score, Advise to continue anticoagulant treatment after 3 months, Advise to discontinue anticoagulant treatment after 3 months
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomised treatment advice (discontinue vs continue after 3 months)Other
Randomisation to continue or discontinue anticoagulant therapy in 1:1 ratio stratified on risk category of L-TRRiP and VTE-BLEED score
VTE-BLEED scoreDiagnostic test
Predict bleeding risk during extended anticoagulant treatment (high or low) using the VTE-BLEED score
L-TRRiP scoreDiagnostic test
Predict VTE recurrence risk after anticoagulant discontinuation (high, intermediate or low) using the L-TRRiP score
Advise to continue anticoagulant treatment after 3 monthsOther
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 monthsOther
Advise to discontinue anticoagulant treatment after 3 months for patients with low VTE recurrence risk
| Study group | Role | What they receive |
|---|---|---|
| Continue anticoagulation | Other | Patients with high recurrent VTE risk and low major bleeding risks are advised to continue anticoagulant therapy. Receives: Diagnostic Test: VTE-BLEED score; Diagnostic Test: L-TRRiP score; Other: Advise to continue anticoagulant treatment after 3 months |
| Discontinue anticoagulation | Other | Patients with low recurrent VTE risk are advised to discontinue anticoagulant therapy. Receives: Diagnostic Test: VTE-BLEED score; Diagnostic Test: L-TRRiP score; Other: Advise to discontinue anticoagulant treatment after 3 months |
| Randomised to continue anticoagulation | Other | Patients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy. Receives: Other: Randomised treatment advice (discontinue vs continue after 3 months); Diagnostic Test: VTE-BLEED score; Diagnostic Test: L-TRRiP score |
| Randomised to discontinue anticoagulation | Other | Patients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy. Receives: Other: Randomised treatment advice (discontinue vs continue after 3 months); Diagnostic Test: VTE-BLEED score; Diagnostic Test: L-TRRiP score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent VTE and major bleeding
Incidence of the combined endpoint recurrent VTE and major bleeding in the randomised arms
Measured: 2 years
Secondary outcomes (9)
Primary outcome weighted for quality of life (EQ-5D-5L)
Recurrent VTE and major bleeding weighted for the impact on quality of life as measured by the EQ-5D-5L
Measured: 2 years
Primary outcome weighted for functional status (PFVS)
Recurrent VTE and major bleeding weighted for the impact on functional limitations as measured by the Post-VTE functional status scale (PFVS) a grade for functional outcomes after a VTE, ranging from grade 0 (no functional limitations, symptoms, pain or anxiety) to grade 4 (severe functional limitations, requiring assistance in activities of daily living) or death..
Measured: 2 years
Cost-effectiveness
For the analysis of cost-effectiveness health care costs and productivity losses will be measured every 3 months during follow-up by the Medical Consumption Questionnaire and Productivity Costs Questionnaire from the institute for Medical Technology Assessment. Health care costs will be calculated using Dutch standard prices for economic evaluations. Absence from work will be valued with friction cost method. Quality Adjusted Life Years (QALYs) will be assessed using the EQ-5D-5L score, which is taken every 3 months during follow-up, using the area-under-the-curve approach. Economic evaluation will consists of both a study-based cost-effectiveness analysis (cost per event) as well as cost-utility analysis with a lifetime horizon (costs per QALY).
Measured: Up to 2 years
Recurrent VTE and major bleeding in non-randomised arms
Incidence of the combined endpoint in the non-randomised arms
Measured: 2 years
Clinically relevant non-major bleeding
Incidence of clinically relevant non-major bleeding in different study arms
Measured: 2 years
Reccurent VTE, major bleeding and clinically relevant - non Major bleeding during entire follow-up
Incidence of recurrent VTE, major bleeding and clinically relevant bleeding in different study arms for the entire duration of follow-up (expected to vary between 2 to 6 years)
Measured: Up to 6 years
Predictive performance of the L-TRRiP model
Discrimination and calibration of L-TRRiP model in the arms that discontinue anticoagulant treatment
Measured: Up to 6 years
Predictive performance of the VTE-BLEED model
Discrimination and calibration of the L-TRRiP model in the arms that continue anticoagulant treatment
Measured: Up to 6 years
Natural course of recovery
Natural course of recovery with regard to long-term functional limitations, measured by post VTE functional status scale every 3 months through the follow-up period of 2 years. Using the post VTE functional status scale (PFVS) a grade for functional outcomes after a VTE, ranging from grade 0 (no functional limitations, symptoms, pain or anxiety) to grade 4 (severe functional limitations, requiring assistance in activities of daily living) or death.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start18 Jun 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with low recurrent VTE risk are advised to stop anticoagulant therapy. Patients with high recurrent VTE risk and low bleeding risk are advised to continue anticoagulant therapy. Patients with intermediate recurrent VTE risk, or high recurrent VTE risk and high bleeding risk are randomised to stop or continue anticoagulant therapy.
- Masking
- None (open label)
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne C. Cannegieter, MD PhD, Leiden University Medical Center
- Investigators
- Suzanne Cannegieter, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087952
- Sponsor's protocol ID
- P20.090
- Other IDs
- 848017007, NL74711.058.20, NL9003
- Acronym
- L-TRRiP
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38521524
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leiden Thrombosis Recurrence Risk Prevention: Tailored Treatment After a First Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT06087952
- Acronym / sponsor ID
- L-TRRiP / P20.090
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 bleeding. The L-TRRiP and VTE-BLEED prediction scores have been developed to classify the risk of recurrent VTE (low, intermediate, high) and major bleeding (low vs high), respectively. However, their combined use in finding the optimal balance to minimize both long-term risks is unclear.
Aims: To evaluate tailored duration of long-term anticoagulant treatment based on individualized risk assessments of recurrent VTE and major bleeding risks.
Methods:
The L-TRRiP study is a multicenter, open-label, cohort based randomized controlled trial in which patients with a first VTE will be included. For each patient the risk of recurrent VTE (low, medium, high) and major bleeding (low, high) will be determined using the L-TRRiP and VTE-BLEED prediction scores, respectively. After three months of initial anticoagulant therapy, patients with a low recurrent VTE risk (<6% in 2 years) will discontinue anticoagulants, whereas patients with a high recurrent VTE risk(>14% in 2 years) and low major bleeding risk will continue. The other groups, with unclear benefit of prolonged treatment, will be randomized to continue or discontinue anticoagulants. Patients will be followed for at least two years, during which they will be asked to fill in a questionnaire every 3 months during the first two years, followed by a questionnaire once a year for the remaining duration of the study (i.e., 2 years after inclusion of the last participant; which is expected to be in 2027). The total follow-up duration is therefore expected to vary between 2 to 6 years. The follow-up questionnaires are used to screen for potential outcomes (including recurrent VTE and bleeding), and includes the EQ-5D-5L to assess quality of life, the Post VTE functional status scale to assess functional outcomes and the Medical Consumption and Productivity Costs Questionnaire to asses cost-effectiveness. In case of a potential outcome additional information is retrieved from the medical record for adjudication. The clinical outcomes will be evaluated and classified by an independent committee blinded for treatment allocation.
Sample size: The sample size of this study is based on the randomized part of the study. To demonstrate a 7% difference in the combined endpoint (i.e., 10.6% vs 3.6%) with an alpha of 0.05 and a power of 90%, a sample size of 552 subjects for the randomized part of the study is required. Taking into account a drop-out rate of 10%, the aim is to include 608 patients in the randomized part of the study. After inclusion of 608 randomized patients, inclusion will stop. Based on the derivation studies it is expected the randomized group will form about 40% of the total included population, in which case the estimated total number of included patients will be 1600. Of note, this total number may change depending on the final proportion of the randomized group.
Ethics: The study has been approved by the Medical Ethics Committee Leiden Den Haag Delft. All participants will provide informed consent.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients with low recurrent VTE risk are advised to stop anticoagulant therapy. Patients with high recurrent VTE risk and low bleeding risk are advised to continue anticoagulant therapy. Patients with intermediate recurrent VTE risk, or high recurrent VTE risk and high bleeding risk are randomised to stop or continue anticoagulant therapy.
| Arm | Type | Receives |
|---|---|---|
| Continue anticoagulation | Other | Diagnostic Test: VTE-BLEED score, Diagnostic Test: L-TRRiP score, Other: Advise to continue anticoagulant treatment after 3 monthsPatients with high recurrent VTE risk and low major bleeding risks are advised to continue anticoagulant therapy. |
| Discontinue anticoagulation | Other | Diagnostic Test: VTE-BLEED score, Diagnostic Test: L-TRRiP score, Other: Advise to discontinue anticoagulant treatment after 3 monthsPatients with low recurrent VTE risk are advised to discontinue anticoagulant therapy. |
| Randomised to continue anticoagulation | Other | Other: Randomised treatment advice (discontinue vs continue after 3 months), Diagnostic Test: VTE-BLEED score, Diagnostic Test: L-TRRiP scorePatients 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 | Other | Other: Randomised treatment advice (discontinue vs continue after 3 months), Diagnostic Test: VTE-BLEED score, Diagnostic Test: L-TRRiP scorePatients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Randomised to continue anticoagulation, Randomised to discontinue anticoagulation |
| VTE-BLEED scorePredict bleeding risk during extended anticoagulant treatment (high or low) using the VTE-BLEED score | Diagnostic test | Continue anticoagulation, Discontinue anticoagulation, Randomised to continue anticoagulation, Randomised to discontinue anticoagulation |
| L-TRRiP scorePredict VTE recurrence risk after anticoagulant discontinuation (high, intermediate or low) using the L-TRRiP score | Diagnostic test | Continue anticoagulation, Discontinue anticoagulation, Randomised to continue anticoagulation, Randomised to discontinue anticoagulation |
| Advise to continue anticoagulant treatment after 3 monthsAdvise to continue anticoagulant treatment after 3 months for patients with high VTE recurrence and low bleeding risk | Other | Continue anticoagulation |
| Advise to discontinue anticoagulant treatment after 3 monthsAdvise to discontinue anticoagulant treatment after 3 months for patients with low VTE recurrence risk | Other | Discontinue anticoagulation |
Primary outcome
Recurrent VTE and major bleeding
Time frame: 2 years
Incidence of the combined endpoint recurrent VTE and major bleeding in the randomised arms
9 secondary outcomes
Primary outcome weighted for quality of life (EQ-5D-5L)
Time frame: 2 years
Primary outcome weighted for functional status (PFVS)
Time frame: 2 years
Cost-effectiveness
Time frame: Up to 2 years
Recurrent VTE and major bleeding in non-randomised arms
Time frame: 2 years
Clinically relevant non-major bleeding
Time frame: 2 years
Reccurent VTE, major bleeding and clinically relevant - non Major bleeding during entire follow-up
Time frame: Up to 6 years
Predictive performance of the L-TRRiP model
Time frame: Up to 6 years
Predictive performance of the VTE-BLEED model
Time frame: Up to 6 years
Natural course of recovery
Time frame: Up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Derived from this study: PubMed 38521524Burggraaf-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Cannegieter, MD, PhD principal investigator
Leiden University Medical Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomised treatment advice (discontinue vs continue after 3 months), VTE-BLEED score and L-TRRiP score in people with Venous Thromboembolism and Venous Thromboses, run by Leiden University Medical Center at 19 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent VTE and major bleeding (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.