Patients with a history of atrial fibrillation undergoing mitral valve repair surgery for mitral regurgitation, requiring anti-coagulation after surgery Circulatory System
Conditions
Interventions
Intervention arm: Direct Oral Anti-Coagulants (DOACs)
Participants allocated to the intervention arm will be prescribed any commercially available DOAC (e.g., apixaban, edoxaban, dabigatran, rivaroxab
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years old or over 2. Confirmed pre-op Atrial Fibrillation (AF) which should be persistent or permanent 3. Undergone Mitral Valve repair surgery* 4. Require prolonged anticoagulation after MVr surgery e.g. for permanent or persistent AF 5. Provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Received a mitral valve replacement or any other valve replacement. 2. Anticoagulation contraindicated 3. Already taking long-term anticoagulation unrelated to an atrial arrhythmia 4. Antiphospholipid syndrome with triple positive antibodies 5. Patients who are pregnant or breastfeeding at the time eligibility is confirmed. 6. Patients with severe renal impairment (defined as creatinine clearance <15 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures: All-cause mortality, major cardiovascular events or major bleeding events will be measured through the collection of patient-reported outcomes and medical record data capture of each of these events, at 3 months, 12 months and then annually for up to 4 years, from the date of randomisation until the end of the trial. Primary Economic Outcome Measures: The incremental cost per quality-adjusted life year (QALY) gained based on responses to the EQ-5D-5L at 1 year post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Economic Outcome Measures: 1. Costs to NHS, patients, and lifetime cost-effectiveness measured by a Health Resource Usage Questionnaire at 3 months, 1 year, and annually, up to 4 years from randomisation. 2. Health status at baseline, 3 months, 1 year, and annually, up to 4 years from randomisation, measured by the EQ-5D-5L questionnaire. Secondary Outcomes Measures: 1. Safety outcomes defined as any bleeding up to 4 years post-randomisation, measured by the collection of data from patient-reported outcomes and medical records at 3 months, 1 year, and annually, up to 4 years from randomisation. 2. Clinical effectiveness outcomes defined as a composite of cardiovascular deaths and systemic thromboembolic complications/events for the duration of the trial, measured by the collection of data from patient-reported outcomes and medical records at 3 months, 1 year, and annually, up to 4 years from randomisation. 3. Adverse events of special interest (neurological events, non-CNS emboli, venous thromboembolic events, heart failure, major bleeding, non-major bleeding, cardiovascular mortality), measured by the collection of data from patient-reported outcomes and medical records, at 3 months, 1 year, and annually, up to 4 years from randomisation. 4. Adherence with therapeutic strategies up to 4 years post-randomisation, measured by the collection of data from patient-reported outcomes and medical records at 3 months, 1 year, and annually, up to 4 years from randomisation. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactAFFECT Trial Team
Outcome results
None listed