NCT07246005

Brief 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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
12mo left

Started Dec 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

October 17, 2025

Last Update Submit

February 26, 2026

Conditions

Left Ventricular Thrombus

Keywords

LVTLeft Ventricular ThrombusThrombusThrombianticoagulant

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Major Bleeding

    6 months

  • Minor Bleeding

    6 months.

  • New LV Thrombi

    6 months

  • Resolved Thrombus

    6 months

  • Hospitalisation

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Continue pre prescribed rivaroxaban or apixaban or warfarin

EXPERIMENTAL

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

Discontinue pre prescribed rivaroxaban or apixaban or warfarin

EXPERIMENTAL

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

Interventions

Continue rivaroxaban or apixaban or warfarinDRUG

The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.

Continue pre prescribed rivaroxaban or apixaban or warfarin
Discontinue rivaroxaban or apixaban or warfarinDRUG

discontinue rivaroxaban or apixaban or warfarin

Discontinue pre prescribed rivaroxaban or apixaban or warfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Bartholomews Hospital

London, EC1A4BE, United Kingdom

Location

MeSH Terms

Conditions

Thrombosis

Interventions

apixabanWarfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Dr Dan Jones

CONTACT

02037658707dan.jones8@nhs.net

Mervyn Andiapen

CONTACT

02037658707mervyn.andiapen@nhs.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2025

First Posted

November 24, 2025

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

GB(1)