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NCT Number: NCT07246005

LVT DURATION: Pilot Study of Anticoagulation Duration 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

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Key information

Conditions

Left Ventricular Thrombus Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Bartholomews Hospital

London, EC1A4BE, United Kingdom

Location contact

Dr Dan Jones

PRINCIPAL_INVESTIGATOR

Mervyn Andiapen

CONTACT

[email protected]

02037658707

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Stroke and Systemic Embolism (SSE)

    Time frame: 6 months

    Number of SSE events following randomisation

  2. All-Cause Mortality

    Time frame: 6 months

    Number of deaths from any cause following randomisation

Secondary outcomes

  1. Major Bleeding

    Time frame: 6 months

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

  2. Minor Bleeding

    Time frame: 6 months.

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

  3. New LV Thrombi

    Time frame: 6 months

    Rates of new LV thrombus formation between the groups.

  4. Resolved Thrombus

    Time frame: 6 months

    Rates of LV thrombus resolution between the groups.

  5. Hospitalisation

    Time frame: 6 months

    Total number of days in hospital between continuing versus stopping anticoagulation.

  6. Cost Comparison

    Time frame: 6 months

    Total measured costs between continuing versus stopping anticoagulation.

  7. MI

    Time frame: 6 months

    Number of participants experiencing MI following randomisation

  8. EQ-5D-5L

    Time frame: 6 months

    Quality of life of participants measured by EQ-5D-5L.

  9. Perspectives of Clinicians and Patients

    Time frame: 6 months

    Qualitative assessment of clinician and patient views on study design, procedures, and relevance, collected via structured interviews and surveys

  10. Target Vessel Revascularization (TVR)

    Time frame: 6 months

    Number of participants undergoing TVR following randomisation

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Dan Jones

CONTACT

[email protected]

02037658707

Mervyn Andiapen

CONTACT

[email protected]

02037658707

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: LVT Duration

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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