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
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the combination of recurrent VTE and major bleeding
events.
Secondary outcome
Secondary outcomes are 1) the combined endpoint (recurrent VTE and major
bleeding) with both events weighted by the associated quality-adjusted life
year (QALY) loss and 2) cost-effectiveness.
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
A cohort-based, randomised, controlled, open trial with blinded endpoint
assessment and at least 2 years follow-up.
Intervention
Individual estimation of risks and benefits of continuation of treatment based
on the VTE-BLEED and L-TRRiP model; and treatment decision based on these
risks. Discontinuation of anticoagulation for those with a low risk of
recurrent thrombosis, continuation of anticoagulation for those with a high
risk of reccurent thrombosis and low risk of major bleeding, randomisation to
continuation or discontinuation of anticoagulation in the other 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.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures.
2. 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.
3. Be aged 18 years or above.
Exclusion criteria
1. 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
2. Patients who need to continue anticoagulant treatment for another indication
(e.g. atrial fibrillation).
3. Patients with a strong indication for long-term antiplatelet therapy despite
oral anticoagulation (e.g. those with recent STEMI)
4. Patients with COVID-19 associated VTE (i.e. hospital admission because of
COVID-19 <3 months before VTE) or vaccine-induced immune thrombotic
thrombocytopenia (VITT)
5. 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
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74711.058.20 |
| Other | NL9003 |