Left Ventricular ThrombusPhase 2LVT DurationNCT07246005
LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus
A Phase 2 study testing Continue rivaroxaban or apixaban or warfarin and Discontinue rivaroxaban or apixaban or warfarin in people with Left Ventricular Thrombus, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Thrombus
- What is being tested?
- Continue rivaroxaban or apixaban or warfarin and Discontinue rivaroxaban or apixaban or warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
St Bartholomews Hospital
London, EC1A4BE
Mervyn Andiapen, 02037658707, mervyn.andiapen@nhs.net
Dr Dan Jones
About this study
Official title: 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
- Conditions
- Left Ventricular Thrombus
- Being tested
- Continue rivaroxaban or apixaban or warfarin, Discontinue rivaroxaban or apixaban or warfarin
- Keywords
- LVT, Left Ventricular Thrombus, Thrombus, Thrombi, anticoagulant
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue rivaroxaban or apixaban or warfarinDrug
The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.
Discontinue rivaroxaban or apixaban or warfarinDrug
discontinue rivaroxaban or apixaban or warfarin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Discontinue rivaroxaban or apixaban or warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke and Systemic Embolism (SSE)
Number of SSE events following randomisation
Measured: 6 months
All-Cause Mortality
Number of deaths from any cause following randomisation
Measured: 6 months
Secondary outcomes (10)
Major Bleeding
Rates of major bleeding (BARC ≥ 3) events following randomisation.
Measured: 6 months
Minor Bleeding
Rates of minor bleeding (BARC ≤ 2) events following randomisation.
Measured: 6 months.
New LV Thrombi
Rates of new LV thrombus formation between the groups.
Measured: 6 months
Resolved Thrombus
Rates of LV thrombus resolution between the groups.
Measured: 6 months
Hospitalisation
Total number of days in hospital between continuing versus stopping anticoagulation.
Measured: 6 months
Cost Comparison
Total measured costs between continuing versus stopping anticoagulation.
Measured: 6 months
MI
Number of participants experiencing MI following randomisation
Measured: 6 months
EQ-5D-5L
Quality of life of participants measured by EQ-5D-5L.
Measured: 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
Measured: 6 months
Target Vessel Revascularization (TVR)
Number of participants undergoing TVR following randomisation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular ThrombusStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246005
- Sponsor's protocol ID
- 1008221
- Other IDs
- G-002409
- Acronym
- LVT Duration
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Pilot Study Assessing the Optimal Duration of Anticoagulation for Left Ventricular Thrombus
- ClinicalTrials.gov ID
- NCT07246005
- Acronym / sponsor ID
- LVT Duration / 1008221
- Conditions
- Left Ventricular Thrombus
- Keywords
- LVT, Left Ventricular Thrombus, Thrombus, Thrombi, anticoagulant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue pre prescribed rivaroxaban or apixaban or warfarin | Experimental | Drug: Continue rivaroxaban or apixaban or warfarinIf randomised to this arm, participants will continue on their rivaroxaban or apixaban or warfarin for the study related time period. |
| Discontinue pre prescribed rivaroxaban or apixaban or warfarin | Experimental | Drug: Discontinue rivaroxaban or apixaban or warfarinIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continue rivaroxaban or apixaban or warfarinThe study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis. | Drug | Continue pre prescribed rivaroxaban or apixaban or warfarin |
| Discontinue rivaroxaban or apixaban or warfarindiscontinue rivaroxaban or apixaban or warfarin | Drug | Discontinue pre prescribed rivaroxaban or apixaban or warfarin |
Primary outcome
Stroke and Systemic Embolism (SSE)
Time frame: 6 months
Number of SSE events following randomisation
All-Cause Mortality
Time frame: 6 months
Number of deaths from any cause following randomisation
10 secondary outcomes
Major Bleeding
Time frame: 6 months
Minor Bleeding
Time frame: 6 months.
New LV Thrombi
Time frame: 6 months
Resolved Thrombus
Time frame: 6 months
Hospitalisation
Time frame: 6 months
Cost Comparison
Time frame: 6 months
MI
Time frame: 6 months
EQ-5D-5L
Time frame: 6 months
Perspectives of Clinicians and Patients
Time frame: 6 months
Target Vessel Revascularization (TVR)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Continue rivaroxaban or apixaban or warfarin and Discontinue rivaroxaban or apixaban or warfarin in people with Left Ventricular Thrombus, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Dan Jones (02037658707, dan.jones8@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke and Systemic Embolism (SSE) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.