Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE)

• Applicants: Professor Dr. Paulus Kirchhof; Professor Dr. Götz Thomalla
• Subject Area: Clinical Neurology; Neurosurgery and Neuroradiology
• Term: since 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 535121142

Atrial fibrillation is one of the most frequent causes of ischemic stroke, and patients with stroke and atrial fibrillation are at high risk of recurrent stroke and cardiovascular complications. Usual care after stroke from atrial fibrillation comprises oral anticoagulation, optimization of cardiovascular risk factors and rate control. While recent data suggest that rhythm-control therapy can improve stroke prevention in patients with atrial fibrillation, it is not known whether this is also effective in patients with acute ischemic stroke and atrial fibrillation. Treatment for early rhythm control in acute stroke patients with atrial fibrillation is only rarely used in clinical practice. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) is an investigator-initiated, randomized, open, blinded endpoint assessment (PROBE) interventional multicenter trial to test whether early rhythm-control therapy in addition to usual care prevents adverse cardiovascular outcome in patients with acute ischemic and atrial fibrillation compared to usual care alone. Early rhythm-control therapy will comprise antiarrhythmic drugs which can be supplemented with atrial fibrillation ablation. Patients should be randomized as early as possible and no later than 4 weeks after the stroke. Primary outcome is a composite of recurrent ischemic stroke, intracerebral haemorrhage, cardiovascular death, and hospitalization due to heart failure or acute coronary syndrome. Secondary outcomes involve an array of clinical parameters, health and socio-economic outcomes including patient reported outcome measures (PROMs). Safety outcomes comprise all-cause mortality, major bleeding, and adverse events related to rhythm control including proarrhythmia and complications due to rhythm-control interventions. In an adaptive design, 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power. A duration of the entire trial of around 5 years is expected. All patients will be followed-up until the end of the trial with a minimum follow-up period of 24 months and an expected mean follow-up period of 42 months. EAST-STROKE is planned as an international trial with companion trials in several countries. Trial organization will rely on established trial networks in the participating countries. Central trial management and coordination will be based in Germany. In Germany, 495 patients will be randomized in 27 study sites. The trial will be organized by a consortium of researchers from cardiology and neurology with longstanding experience in clinical trials of stroke and atrial fibrillation. The results of EAST-STROKE are expected to change current standards of treatment of atrial fibrillation in stroke and by this help in avoiding recurrent stroke and cardiovascular complications in many patients.

• DFG Programme: Clinical Trials
• Co-Investigator: Dr. Märit Jensen