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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen Mary University of London

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Continue pre prescribed rivaroxaban or apixaban or warfarinExperimental treatment 1 intervention
Group B: Discontinue pre prescribed rivaroxaban or apixaban or warfarinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stroke and Systemic Embolism (SSE)

Number of SSE events following randomisation

Time frame
6 months
2

All-Cause Mortality

Number of deaths from any cause following randomisation

Time frame
6 months

Secondary outcomes

1

Major Bleeding

Rates of major bleeding (BARC ≥ 3) events following randomisation.

Time frame
6 months
2

Minor Bleeding

Rates of minor bleeding (BARC ≤ 2) events following randomisation.

Time frame
6 months.
3

New LV Thrombi

Rates of new LV thrombus formation between the groups.

Time frame
6 months
4

Resolved Thrombus

Rates of LV thrombus resolution between the groups.

Time frame
6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: