Left ventricle thrombus based on aetiology- Acute Coronary Syndrome Circulatory System
Conditions
Interventions
Patients with a diagnosis of left ventricular (LV) thrombus in the context of acute coronary syndrome (ACS) will be pre screened. As part of standard clinical care, all patients will already have unde
dose and frequency according to the licensed regimen for each agent). No changes to treatment will be introduced by the study.
Arm 2 – Stop Oral Anticoagulation: Participants will discontinue their or
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of LV thrombus less than 12 months ago 2. Ongoing oral anticoagulation treatment at time of randomisation 3. Completed at least 3 months of anticoagulation treatment for LV thrombus 4. Persistent laminar/ mural thrombus or persistent LV dysfunction
Exclusion criteria
Exclusion criteria: 1. Any clinical condition requiring long term anticoagulation treatment as per investigator’s judgement. 2. SSE since LV thrombus diagnosis 3. Contraindication to continuing anticoagulation therapy 4. Non-ischaemic Cardiomyopathy 5. Age less than 18 years 6. Unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite outcome of systemic thromboembolism (SSE) and all cause mortality is measured using clinical event data obtained from hospital records and study follow up at baseline and at 6 months (±3 months) after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major bleeding events (BARC = 3) are measured using clinical event reporting and hospital records at baseline and at 6 months (±3 months) after randomisation. 2. Minor bleeding events (BARC = 2) are measured using clinical event reporting and hospital records at baseline and at 6 months (±3 months) after randomisation. 3. New left ventricular (LV) thrombus formation is measured using echocardiography or cardiac imaging at baseline and at 6 months (±3 months). 4. LV thrombus resolution is measured using echocardiography or cardiac imaging at baseline and at 6 months (±3 months). 5. Total number of days spent in hospital is measured using hospital admission records from randomisation to 6 months (±3 months). 6. Total healthcare costs are measured using resource use data and standard costing methods from randomisation to 6 months (±3 months). 7. Myocardial infarction (MI) and target vessel revascularisation (TVR) events are measured using hospital records and clinical follow up at baseline and at 6 months (±3 months). 8. Quality of life is measured using the EQ 5D 5L questionnaire at baseline and at 6 months (±3 months). 9. Clinician and patient perspectives on the study are measured using qualitative interviews or structured questionnaires conducted during the study period up to 6 months (±3 months). | — |
Countries
England, United Kingdom
Contacts
Public ContactMervyn Andiapen
Outcome results
None listed