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

Queen Mary University of London

Status and phase: Not yet enrolling; Phase 2

Conditions: Left Ventricular Thrombus

Treatments: Drug: Continue rivaroxaban or apixaban or warfarin; Drug: Discontinue rivaroxaban or apixaban or warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT07246005

G-002409 (Other Grant/Funding Number)

1008221

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Continue pre prescribed rivaroxaban or apixaban or warfarin

Experimental group

Description:

If randomised to this arm, participants will continue on their rivaroxaban or apixaban or warfarin for the study related time period.

Treatment:

Drug: Continue rivaroxaban or apixaban or warfarin

Discontinue pre prescribed rivaroxaban or apixaban or warfarin

Experimental group

Description:

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.

Treatment:

Drug: Discontinue rivaroxaban or apixaban or warfarin