ASPIRE-AF
Research type
Research Study
Full title
Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial
IRAS ID
1005338
Contact name
David Wright
Contact email
Sponsor organisation
Population Health Research Institute
Eudract number
2019-001336-62
Clinicaltrials.gov Identifier
Research summary
When under going non cardiac surgery about 3 % of patients develop a common arrhythmia called atrial fibrillation (AF). Patients with perioperative atrial fibrillation (AF) have a substantial risk of stroke and other adverse outcomes. Clinicians face a difficult decision regarding whether to use anticoagulation in this large group of patients with perioperative AF after noncardiac surgery without any
high-quality data to inform this issue. They must balance the potential benefit of anticoagulation in reducing the risk of stroke (proven in large scale studies on patients in the non peri-operative setting) against the increased risk of bleeding after recent surgery. At present there is a wide variation in clinical practice. The ASPIRE-AF trial will determine the efficacy and safety of oral anticoagulation in this patient population. This is a Phase IV prospective, randomized, open-label clinical trial with blinded outcome assessment (PROBE design). All patients with perioperative AF within 35 days after noncardiac surgery will be screened for eligibility and, if eligible, approached to participate. Patients will be randomly assigned to the intervention arm or control arm. In the intervention arm, a novel oral anti-coagulant (NOAC) will be initiated after randomization. In the control arm, no anticoagulation will be prescribed, however, single antiplatelet treatment is permitted. Patients will be followed in clinic or by telephone post-randomization at 1 month, 3 months and every 3 months thereafter, up to a maximum of 24 months. The investigators postulate that the use of NOACS in this group of patients will be beneficial in reducing strokes in the longer term in the absence of increasing the risk of bleeding side effects.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0011
Date of REC Opinion
23 Aug 2023
REC opinion
Further Information Favourable Opinion