Short description
Atrial fibrillation (AF) is a common heart rhythm disorder, and stroke is a major complication. While direct oral anticoagulants (DOACs) reduce the risk of stroke in AF patients, some still experience strokes despite treatment. Recent research suggests that most of these strokes are due to “breakthrough” blood clots, and the best way to prevent them is unknown. A study found that combining DOACs with surgical occlusion of the left atrial appendage (LAAO) may be more effective than DOACs alone.
The ELAPSE trial is designed to investigate if adding LAAO to DOAC therapy is superior to standard treatment for preventing strokes in this high-risk population. Hence, AF patients who have had strokes despite anticoagulation will be randomly assigned to receive either DOACs alone or DOACs plus LAAO. The primary goal is to compare the occurrence of recurrent stroke, systemic embolism, and cardiovascular death between the two groups. Based on prior data, the study aims to enrol 482 patients.
Objective
The primary aim of this trial is to evaluate whether in patients with AF and acute stroke despite optimal anticoagulation, a combination of LAAO plus DOAC reduces the risk of the composite endpoint recurrent ischaemic stroke, systemic embolism and cardiovascular death compared to DOAC alone.
Principal Investigators
Prof. Lorenz Räber M.D. PhD
Department of Cariology
Inselspital, Bern University Hospital
Bern, Switzerland
Prof. David Seiffge, M.D.
Department of Neurology
Inselspital, Bern University Hospital
Bern, Switzerland
Prof. Urs Fischer, M.D.
Department of Neurology
Inselspital, Bern University Hospital
Bern, Switzerland