Early rhythm-control therapy for stroke patients with atrial fibrillation
Official title: Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
Run by Universitätsklinikum Hamburg-Eppendorf · NCT05293080 · Data updated 2026-11-12
This trial tests whether starting rhythm-control treatment early after an acute ischemic stroke in people with atrial fibrillation can reduce recurrent strokes and other heart-related problems, compared with usual care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1746 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | November 6, 2025 |
| Main results expected | July 2031 |
| Study ends | September 2031 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT05293080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with acute ischemic stroke within the past four weeks and newly diagnosed atrial fibrillation (AF detected ≤1 year before randomization) who can start rhythm-control therapy within four weeks after stroke.
✕Probably not a fit
Patients who are not suitable for rhythm-control therapy due to other cardiac conditions or who have very limited life expectancy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
EAST-STROKE is a multicenter, randomized, PROBE study designed to see if early comprehensive rhythm control for atrial fibrillation after acute ischemic stroke improves cardiovascular outcomes. Participants may receive antiarrhythmic drugs, ablation, or electrical cardioversion as part of the rhythm-control strategy, or standard care as a control. The primary outcome combines recurrent stroke, cardiovascular death, and hospitalizations for heart failure or acute coronary syndrome, with secondary outcomes including safety, health status, and socio-economic factors. The trial uses an adaptive design and aims to enroll up to 1,746 patients with 90% power. The study is investigator-initiated and includes blinded outcome assessment to reduce bias.
Why it matters
Potential benefit: If successful, early rhythm-control treatment could lower the risk of recurrent strokes and other cardiovascular events after an ischemic stroke in patients with atrial fibrillation.
How similar studies have gone: Prior research in rhythm-control strategies after stroke is limited; this trial tests a comprehensive early approach in a large, multicenter setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis * Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable * AF first detected ≤1 year prior to randomization * Informed consent Exclusion Criteria: * End-stage cancer or life-expectancy \< 12 months due to other advanced co-morbid illness * Prior AF ablation or surgical therapy of AF * Patients not suitable for rhythm control of AF due to cardiac conditions
Where it's running
-
University Medical Center Hamburg-Eppendorf
Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Götz Thomalla, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Märit Jensen, MD
- Email: m.jensen@uke.de
- Phone: +4940741053770
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.