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NCT Number: NCT05293080

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

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.

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Key information

Conditions

Acute Ischemic Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location status: Recruiting

About this study

Atrial 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 for atrial fibrillation

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.

Primary outcomes

  1. Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.

    Time frame: 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

Secondary outcomes

  1. Time to first recurrent stroke

    Time frame: Through study completion, an average of 42 months

    Recurrent stroke as recorded by study investigators

  2. Time to cardiovascular death

    Time frame: Through study completion, an average of 42 months

  3. Time to first hospitalization due to worsening of heart failure

    Time frame: Through study completion, an average of 42 months

    Hospitalization due to worsening of heart failure as recorded by study investigators

  4. Time to hospitalization due to acute coronary syndrome

    Time frame: Through study completion, an average of 42 months

    Hospitalization due to acute coronary syndrome as recorded by study investigators

  5. Time to recurrent AF

    Time frame: Through study completion, an average of 42 months

  6. Cardiovascular hospitalization

    Time frame: Through study completion, an average of 42 months

    Cardiovascular hospitalization as recorded by study investigators

  7. All-cause hospitalizations

    Time frame: Through study completion, an average of 42 months

    All-cause hospitalizations as recorded by study investigators

  8. Time in sinus rhythm

    Time frame: Through study completion, an average of 42 months

  9. Functional status assessed by the modified Rankin Scale

    Time frame: at 12 and 24 months

    Modified Ranking Scale ranging from 0 (no symptoms) to 6 (death) with lower values indicating better status

  10. Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D)

    Time frame: at 12 and 24 months

    The EQ-5D index will be calculated with higher values indicating better health state

  11. Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: at 12 and 24 months

    The MoCA ranges for 0 to 30, with higher values indicating better cognitive function

  12. Cost of therapy

    Time frame: Through study completion, an average of 42 months

Other outcomes

  1. All-cause mortality

    Time frame: Through study completion, an average of 42 months

    Death from any cause

  2. Severe bleeding complications

    Time frame: Through study completion, an average of 42 months

    Intracranial hemorrhage, major bleeding

  3. Adverse events

    Time frame: Through study completion, an average of 42 months

    Adverse events related to the study intervention with special emphasis on proarrhythmia and complications due to interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Götz Thomalla, MD

CONTACT

[email protected]

+4940741050137

Märit Jensen, MD

CONTACT

[email protected]

+4940741053770

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • CTC-NORTH
  • Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre
  • Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht
  • Department of Neurology, Royal Melbourne Hospital
  • Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh
  • Hotchkiss Brain Institute, University of Calgary
  • Kompetenznetz Vorhofflimmern e.V. (AFNET)
  • Melbourne Heart Centre, Royal Melbourne Hospital
  • Stroke Alliance for Europe (SAFE)
  • UMC Utrecht
  • University Heart & Vascular Center Hamburg, Department of Cardiology

Registry information

Acronym: EAST-STROKE

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Mar 24, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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