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

NCT05293080 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EAST-STROKE
• Study Type: interventional
• Target: 1,746
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Ischemic Stroke; Atrial Fibrillation

Keywords

Acute ischemic stroke; Atrial fibrillation; Rhythm control; Ablation; Antiarrhythmic drugs

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

• 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

Other Outcomes (3)

• 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

Study Arms (2)

Early rhythm control therapy

EXPERIMENTAL

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.

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

Usual care

ACTIVE COMPARATOR

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

Other: Usual care for atrial fibrillation

Interventions

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.

Early rhythm control therapy

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Götz Thomalla, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Märit Jensen, MD

CONTACT

+4940741053770; m.jensen@uke.de

Götz Thomalla, MD

CONTACT

+4940741050137; thomalla@uke.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 24, 2022
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share