Left Ventricular Thrombus
Conditions
Keywords
LVT, Left Ventricular Thrombus, Thrombus, Thrombi, anticoagulant
Brief summary
The LVT DURATION (Optimal Duration of Anticoagulation for LV Thrombus) is a pilot study planned to assess the practicalities of conducting a randomised control trial (RCT) whilst establishing data around the ideal duration of anticoagulation in the treatment of LV thrombus. The main objectives of the study are: * To assess the practicalities of conducting an RCT with regard to recruitment, retention, and outcome measurement. * To identify the optimal length of anticoagulation in the treatment of LV Thrombus After randomisation participants will: * Continue their prescribed oral anticoagulant for the remainder of the trial * Discontinue their prescribed oral anticoagulant for the remainder of the trial
Interventions
DRUGContinue rivaroxaban or apixaban or warfarin
The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.
DRUGDiscontinue rivaroxaban or apixaban or warfarin
discontinue rivaroxaban or apixaban or warfarin
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of LV thrombus less than 12 months ago * On Apixaban at the time of randomisation * Completed at least 3 months of anticoagulation treatment for LV thrombus * Persistent laminar/ mural thrombus or persistent LV dysfunction
Exclusion criteria
* Any clinical condition requiring long term anticoagulation treatment as per investigator's judgement. * SSE since LV thrombus diagnosis * Contraindication to continuing anticoagulation therapy * Non-ischaemic Cardiomyopathy * Age less than 18 years * Unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 6 months | Number of deaths from any cause following randomisation |
| Stroke and Systemic Embolism (SSE) | 6 months | Number of SSE events following randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New LV Thrombi | 6 months | Rates of new LV thrombus formation between the groups. |
| Resolved Thrombus | 6 months | Rates of LV thrombus resolution between the groups. |
| Hospitalisation | 6 months | Total number of days in hospital between continuing versus stopping anticoagulation. |
| Cost Comparison | 6 months | Total measured costs between continuing versus stopping anticoagulation. |
| MI | 6 months | Number of participants experiencing MI following randomisation |
| EQ-5D-5L | 6 months | Quality of life of participants measured by EQ-5D-5L. |
| Perspectives of Clinicians and Patients | 6 months | Qualitative assessment of clinician and patient views on study design, procedures, and relevance, collected via structured interviews and surveys |
| Major Bleeding | 6 months | Rates of major bleeding (BARC ≥ 3) events following randomisation. |
| Target Vessel Revascularization (TVR) | 6 months | Number of participants undergoing TVR following randomisation |
| Minor Bleeding | 6 months. | Rates of minor bleeding (BARC ≤ 2) events following randomisation. |
Countries
United Kingdom
Contacts
CONTACTDr Dan Jones
CONTACTMervyn Andiapen
Outcome results
None listed