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

NCT05293080 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1746

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)

Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version.

OTHER

Usual care for atrial fibrillation

Usual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients.

Sponsors & Collaborators

  • University Heart & Vascular Center Hamburg, Department of Cardiology

    collaborator UNKNOWN
  • Department of Neurology, Royal Melbourne Hospital

    collaborator UNKNOWN
  • Melbourne Heart Centre, Royal Melbourne Hospital

    collaborator UNKNOWN
  • Hotchkiss Brain Institute, University of Calgary

    collaborator OTHER
  • Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht

    collaborator UNKNOWN
  • UMC Utrecht

    collaborator OTHER
  • Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh

    collaborator UNKNOWN
  • Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre

    collaborator UNKNOWN
  • CTC-NORTH

    collaborator UNKNOWN
  • Stroke Alliance for Europe (SAFE)

    collaborator UNKNOWN
  • Kompetenznetz Vorhofflimmern e.V. (AFNET)

    collaborator UNKNOWN
  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Götz Thomalla, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2031-07-31
Completion
2031-09-30

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293080 on ClinicalTrials.gov