About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Continue rivaroxaban or apixaban or warfarin
DrugThe study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.
Discontinue rivaroxaban or apixaban or warfarin
Drugdiscontinue rivaroxaban or apixaban or warfarin
Treatment groups
Trial outcomes
Primary outcomes
Stroke and Systemic Embolism (SSE)
Number of SSE events following randomisation
All-Cause Mortality
Number of deaths from any cause following randomisation
Secondary outcomes
Major Bleeding
Rates of major bleeding (BARC ≥ 3) events following randomisation.
Minor Bleeding
Rates of minor bleeding (BARC ≤ 2) events following randomisation.
New LV Thrombi
Rates of new LV thrombus formation between the groups.
Resolved Thrombus
Rates of LV thrombus resolution between the groups.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: