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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Left Ventricular Thrombus
• Intervention / Treatment: Drug: Continue rivaroxaban or apixaban or warfarin; Drug: Discontinue rivaroxaban or apixaban or warfarin

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mervyn Andiapen; Phone Number: 02037658707; Email: mervyn.andiapen@nhs.net
• Study Contact Backup: Name: Dr Dan Jones; Phone Number: 02037658707; Email: dan.jones8@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A4BE
    • St Bartholomews Hospital
    • Contact: Mervyn Andiapen; Phone Number: 02037658707; Email: mervyn.andiapen@nhs.net
    • Principal Investigator: Dr Dan Jones

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continue pre prescribed 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.	Drug: Continue rivaroxaban or apixaban or warfarin; The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.
Experimental: Discontinue pre prescribed 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.	Drug: Discontinue rivaroxaban or apixaban or warfarin; discontinue rivaroxaban or apixaban or warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke and Systemic Embolism (SSE)	Number of SSE events following randomisation	6 months
All-Cause Mortality	Number of deaths from any cause following randomisation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Bleeding	Rates of major bleeding (BARC ≥ 3) events following randomisation.	6 months
Minor Bleeding	Rates of minor bleeding (BARC ≤ 2) events following randomisation.	6 months.
New LV Thrombi	Rates of new LV thrombus formation between the groups.	6 months
Resolved Thrombus	Rates of LV thrombus resolution between the groups.	6 months
Hospitalisation	Total number of days in hospital between continuing versus stopping anticoagulation.	6 months
Cost Comparison	Total measured costs between continuing versus stopping anticoagulation.	6 months
MI	Number of participants experiencing MI following randomisation	6 months
EQ-5D-5L	Quality of life of participants measured by EQ-5D-5L.	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	6 months
Target Vessel Revascularization (TVR)	Number of participants undergoing TVR following randomisation	6 months

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Thrombus; anticoagulant; Thrombi; Left Ventricular Thrombus; LVT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Coumarins; Benzopyrans; 4-Hydroxycoumarins; Warfarin; apixaban
• Other Study ID Numbers: 1008221; G-002409 (Other Grant/Funding Number: Barts Charity)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes