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

Last updated: December 27, 2023
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Not Recruiting

Phase

3

Condition

Stroke

Cerebral Ischemia

Arrhythmia

Treatment

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

Usual care for atrial fibrillation

Clinical Study ID

NCT05293080
EAST-STROKE
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) orclinical diagnosis
  • Possibility to start the trial treatment within 4 weeks after stroke, and as soon asclinically justifiable
  • AF first detected ≤1 year prior to randomization
  • Informed consent

Exclusion

Exclusion Criteria:

  • End-stage cancer or life-expectancy < 12 months due to other advanced co-morbidillness
  • Prior AF ablation or surgical therapy of AF
  • Patients not suitable for rhythm control of AF due to cardiac conditions

Study Design

Total Participants: 1746
Treatment Group(s): 2
Primary Treatment: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
Phase: 3
Study Start date:
September 01, 2024
Estimated Completion Date:
March 31, 2029

Study 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.