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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.
discontinue rivaroxaban or apixaban or warfarin
St Bartholomews Hospital
London, United Kingdom
Stroke and Systemic Embolism (SSE)
Number of SSE events following randomisation
Time frame: 6 months
All-Cause Mortality
Number of deaths from any cause following randomisation
Time frame: 6 months
Major Bleeding
Rates of major bleeding (BARC ≥ 3) events following randomisation.
Time frame: 6 months
Minor Bleeding
Rates of minor bleeding (BARC ≤ 2) events following randomisation.
Time frame: 6 months.
New LV Thrombi
Rates of new LV thrombus formation between the groups.
Time frame: 6 months
Resolved Thrombus
Rates of LV thrombus resolution between the groups.
Time frame: 6 months
Hospitalisation
Total number of days in hospital between continuing versus stopping anticoagulation.
Time frame: 6 months
Cost Comparison
Total measured costs between continuing versus stopping anticoagulation.
Time frame: 6 months
MI
Number of participants experiencing MI following randomisation
Time frame: 6 months
EQ-5D-5L
Quality of life of participants measured by EQ-5D-5L.
Time frame: 6 months
Perspectives of Clinicians and Patients
Qualitative assessment of clinician and patient views on study design, procedures, and relevance, collected via structured interviews and surveys
Time frame: 6 months
Target Vessel Revascularization (TVR)
Number of participants undergoing TVR following randomisation
Time frame: 6 months
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