LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continue rivaroxaban or apixaban or warfarin, Discontinue rivaroxaban or apixaban or warfarin.
- Who it may be relevant to
- Registry conditions: Left Ventricular Thrombus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomised Pilot Study Assessing the Optimal Duration of Anticoagulation for Left Ventricular Thrombus
Overview
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
Interventions
- Drug Continue rivaroxaban or apixaban or warfarin
The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis. - Drug Discontinue rivaroxaban or apixaban or warfarin
discontinue rivaroxaban or apixaban or warfarin
Primary outcome measures
- Stroke and Systemic Embolism (SSE) [Time frame: 6 months]
- All-Cause Mortality [Time frame: 6 months]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- St Bartholomews Hospital — London
Identifiers
NCT: NCT07246005 · 1008221 · G-002409