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

NCT05293080 · tracked via the Priya Life Science Germany tracker

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Phase

Phase 3

Started

2025-11-06

Last updated

2026-05-18

Condition(s) studied

Acute Ischemic StrokeAtrial Fibrillation

Investigational drug(s) / intervention(s)

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

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.

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome. — Through study completion, an average of 42 months
The primary outcome measure is a composite of first recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or due to acute coronary syndrome as recorded by study investigators

Trial sites (1)

Facility	City	Region	Status
University Medical Center Hamburg-Eppendorf	Hamburg	Germany	Recruiting

More Universitätsklinikum Hamburg-Eppendorf trials in Germany

External Validation of the MASCAN Score for the Classification of Difficult Mask Ventilation Recruiting

Characterisation of phenotYpes in aCute Heart faiLure patiEnts Recruiting

Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension Recruiting

Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD Active, not recruiting

Cerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Parkinson's Disease Tremor Recruiting

Other trials for the same condition

Non-invasive Differentiation of Supraventricular Tachyarrhythmia Recruiting

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke Recruiting

Clinical Cohort Study - TRUST Recruiting

VOLT CE Mark Study Active, not recruiting

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05293080 on ClinicalTrials.gov ↗ ← All trials in Germany