NCT05293080|RecruitingPhase 3DMC
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
EAST-STROKE
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Sponsor study identifier
interventional
1,746
7 countries
13
Study Start
November 6, 2025
Actual (reported)Primary Completion
July 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2022
Actual (reported)March 24, 2022
Actual (reported)November 6, 2025
Actual (reported)July 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
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
Through study completion, an average of 42 months
Time to first recurrent stroke
Through study completion, an average of 42 months
Time to cardiovascular death
Through study completion, an average of 42 months
Patients with acute ischemic stroke and AF will receive either catheter ablation (mainly pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. In case of continuation or recurrence of AF, both modalities may be combined.
Patients with acute ischemic stroke and AF will receive usual care following the current ESC guidelines for AF treatment.
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 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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
AMIODARONE HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
FLECAINIDE ACETATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
AMIODARONE HYDROCHLORIDE
Named ingredient: Amiodarone hydrochloride
View registry recordFLECAINIDE ACETATE
Named ingredient: Flecainide acetate
View registry recordUniversity Medical Center Hamburg-Eppendorf
Hamburg, Germany
Jensen M, Zapf A, Buchholz A, Mohl A, Andrade JG, Cameron A, Campbell BCV, Fischer U, Hill MD, Kelly P, Kalman JM, Loh P, Molina C, Guasch E, Metzner A, Ng GA, Pagola J, Pontes-Neto OM, Reichlin T, Salman RA, Shoamanesh A, Sposato LA, van der Worp HB, Kirchhof P, Thomalla G. Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE): protocol for an international investigator-initiated, prospective, randomised, open, blinded endpoint assessment (PROBE) interventional multi-centre trial. Eur Stroke J. 2026 May 6;11(5):aakag022. doi: 10.1093/esj/aakag022.
Götz Thomalla, MD
Universitätsklinikum Hamburg-Eppendorf
First Submitted
March 1, 2022
First Posted
March 24, 2022
Study Start
November 6, 2025
Actual (reported)Primary Completion
July 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Time to first hospitalization due to worsening of heart failure
Through study completion, an average of 42 months
Time to hospitalization due to acute coronary syndrome
Through study completion, an average of 42 months
Time to recurrent AF
Through study completion, an average of 42 months
All-cause mortality
Through study completion, an average of 42 months
Severe bleeding complications
Through study completion, an average of 42 months
Adverse events
Through study completion, an average of 42 months
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Study Completion
September 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 18, 2026
Record last verified: 2026-05
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