Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE (EAST-STROKE)

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Not yet enrolling; Phase 3

Conditions: Atrial Fibrillation; Acute Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05293080

EAST-STROKE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,746 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,746 participants in 2 patient groups

Early rhythm control therapy

Experimental group

Description:

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.

Treatment:

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

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual care for atrial fibrillation