LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus

NCT07246005 — Phase 2, Not yet recruiting, 120 participants, Queen Mary University of London

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A Randomised Pilot Study Assessing the Optimal Duration of Anticoagulation for Left Ventricular Thrombus

Registry	NCT07246005, acronym LVT Duration
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	Queen Mary University of London (Other)
Conditions	Left Ventricular Thrombus
Interventions	Continue rivaroxaban or apixaban or warfarin, Discontinue rivaroxaban or apixaban or warfarin (Drug)
Dates	start 2026-12-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2025-11-24, last updated 2026-02-27
Locations	1 site in United Kingdom

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Continue pre prescribed rivaroxaban or apixaban or warfarin	Experimental	Drug: Continue rivaroxaban or apixaban or warfarin	If randomised to this arm, participants will continue on their rivaroxaban or apixaban or warfarin for the study related time period.
Discontinue pre prescribed rivaroxaban or apixaban or warfarin	Experimental	Drug: Discontinue rivaroxaban or apixaban or warfarin	If randomised to this arm, patients (who have already been on OAC for a period of 3 months) will discontinue their rivaroxaban or apixaban or warfarin.

Continue rivaroxaban or apixaban or warfarin (Drug): The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.
Discontinue rivaroxaban or apixaban or warfarin (Drug): discontinue rivaroxaban or apixaban or warfarin

+Outcome measures

Primary outcomes

Stroke and Systemic Embolism (SSE) [6 months]: Number of SSE events following randomisation
All-Cause Mortality [6 months]: Number of deaths from any cause following randomisation

Secondary outcomes

Major Bleeding [6 months]: Rates of major bleeding (BARC ≥ 3) events following randomisation.
Minor Bleeding [6 months.]: Rates of minor bleeding (BARC ≤ 2) events following randomisation.
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
Target Vessel Revascularization (TVR) [6 months]: Number of participants undergoing TVR following randomisation

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
St Bartholomews Hospital	London	United Kingdom