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Recruiting Phase 3 NCT05293080

NCT05293080 Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE

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Clinical Trial Summary
NCT ID NCT05293080
Status Recruiting
Phase Phase 3
Sponsor Universitätsklinikum Hamburg-Eppendorf
Condition Acute Ischemic Stroke
Study Type INTERVENTIONAL
Enrollment 1,746 participants
Start Date 2025-11-06
Primary Completion 2031-07

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)Usual care for atrial fibrillation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 1,746 participants in total. It began in 2025-11-06 with a primary completion date of 2031-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.

Eligibility 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

Contact & Investigator

Central Contact

Märit Jensen, MD

✉ m.jensen@uke.de

📞 +4940741053770

Principal Investigator

Götz Thomalla, MD

PRINCIPAL INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Frequently Asked Questions

Who can join the NCT05293080 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05293080 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,746 participants.

Is NCT05293080 currently recruiting?

Yes, NCT05293080 is actively recruiting participants. Contact the research team at m.jensen@uke.de for enrollment information.

Where is the NCT05293080 trial being conducted?

This trial is being conducted at Hamburg, Germany.

Who is sponsoring the NCT05293080 clinical trial?

NCT05293080 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Götz Thomalla, MD at Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 1,746 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology