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

NCT ID: NCT05293080

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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trial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.

Conditions

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Acute Ischemic Stroke Atrial Fibrillation

Keywords

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Acute ischemic stroke Atrial fibrillation Rhythm control Ablation Antiarrhythmic drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early rhythm control therapy

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Patients with acute ischemic stroke and AF will receive usual care following the current ESC guidelines for AF treatment.

Group Type ACTIVE_COMPARATOR

Usual care for atrial fibrillation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Heart & Vascular Center Hamburg, Department of Cardiology

UNKNOWN

Sponsor Role collaborator

Department of Neurology, Royal Melbourne Hospital

UNKNOWN

Sponsor Role collaborator

Melbourne Heart Centre, Royal Melbourne Hospital

UNKNOWN

Sponsor Role collaborator

Hotchkiss Brain Institute, University of Calgary

OTHER

Sponsor Role collaborator

Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht

UNKNOWN

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf

UNKNOWN

Sponsor Role collaborator

CTC-NORTH

UNKNOWN

Sponsor Role collaborator

Stroke Alliance for Europe (SAFE)

UNKNOWN

Sponsor Role collaborator

Kompetenznetz Vorhofflimmern e.V. (AFNET)

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Götz Thomalla, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Central Contacts

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Märit Jensen, MD

Role: CONTACT

Phone: +4940741053770

Email: [email protected]

Götz Thomalla, MD

Role: CONTACT

Phone: +4940741050137

Email: [email protected]

Other Identifiers

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EAST-STROKE

Identifier Type: -

Identifier Source: org_study_id