To determine which patients, individually classified for VTE ánd bleeding risk, will benefit from prolonged anticoagulant treatment without being unnecessarily exposed to its risks.
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Health condition
Venous thromboembolism (deep vein thrombosis and pulmonary embolism)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Secondary outcome
- Combined endpint weighted for quality of life and functional status (measured by EQ-5D and PVFS)
- Recurrent VTE and bleeding in non-randomised groups
- Clinically relevant non-major bleeding
- Cost-effectiveness (measured by the iMTA MCQ and iMTA PCQ questionnaires)
- Functional recovery (measured by post-vte functional status scale)
Background summary
Patients with a first venous thromboembolism (VTE) have a high risk of recurrence. Anticoagulant therapy is effective for prevention but not suitable for long-term treatment of all patients due to its bleeding risk. Currently, it is unclear which patients will benefit most from prolonged treatment and for whom such treatment is redundant. Hence, many patients are over- or undertreated for a prolonged period.
Study objective
To determine which patients, individually classified for VTE ánd bleeding risk, will benefit from prolonged anticoagulant treatment without being unnecessarily exposed to its risks.
Study design
"Study design: A cohort-based, randomised, controlled, open trial with blinded endpoint assessment and at least 2 years follow-up. Study population: Patients without cancer, treated with anticoagulants for a first VTE who are about to complete this treatment. Intervention: Individual estimation of recurrent VTE (low, intermediate or high) and major bleeding risk (low or high) and treatment decision based on these risks. Randomisation to continuation or discontinuation of anticoagulation in a subgroup of patients (i.e. patients with intermediate recurrence risk, or high recurrence risk and high bleeding risk). Sample size: 608 patients in randomised group, total cohort size depending on the distribution of randomised and non-randomised patients. Main study parameters/endpoints: The primary outcome will be the combination of recurrent VTE and major bleeding events. Secondary outcomes are 1) the combined endpoint with both events weighted by the associated quality-adjusted life year (QALY) loss and 2) cost-effectiveness."
Intervention
Individual estimation of risks and benefits of continuation of anticoagulant treatment and treatment decision based on these risks. Randomisation to continuation or discontinuation of anticoagulation in a subgroup of patients.
Study burden and risks
For patients, participation in this study will have as a small extra burden compared with the current policy that short questionnaires need to be filled in throughout the study duration and that a buccal swab will need to be taken at the start of the study. However, no extra visits to the clinic are necessary, nor is extra blood sampling, and the detailed risk assessment and according treatment may benefit their health outcomes.
Prof. dr. S.C. Cannegieter
Albinusdreef 2
Leiden 2333 ZA
NL
+31 6 21 32 28 49
L-TRRiP@lumc.nl
Prof. dr. S.C. Cannegieter
Albinusdreef 2
Leiden 2333 ZA
NL
+31 71 52 61508
J.s.c.cannegieter@lumc.nl
Age
Inclusion criteria
- 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') of the lower extremity 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.
Exclusion criteria
- 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 (i.e. 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.
Design
Recruitment
IPD sharing statement
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9003 |
| Other | METC Leiden Den Haag Delft : P20.090, NL74711.058.20 |
| CCMO | NL74711.058.20 |
| OMON | NL-OMON54327 |