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| Name | Class |
|---|---|
| University Heart & Vascular Center Hamburg, Department of Cardiology | UNKNOWN |
| Department of Neurology, Royal Melbourne Hospital | UNKNOWN |
| Melbourne Heart Centre, Royal Melbourne Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | Active Comparator | Patients with acute ischemic stroke and AF will receive usual care following the current ESC guidelines for AF treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrent stroke | Recurrent stroke as recorded by study investigators | Through study completion, an average of 42 months |
| Time to cardiovascular death | Through study completion, an average of 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Death from any cause | Through study completion, an average of 42 months |
| Severe bleeding complications | Intracranial hemorrhage, major bleeding |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Märit Jensen, MD | Contact | +4940741053770 | m.jensen@uke.de | |
| Götz Thomalla, MD | Contact | +4940741050137 | thomalla@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Götz Thomalla, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42153760 | Derived | Jensen M, Zapf A, Buchholz A, Mohl A, Andrade JG, Cameron A, Campbell BCV, Fischer U, Hill MD, Kelly P, Kalman JM, Loh P, Molina C, Guasch E, Metzner A, Ng GA, Pagola J, Pontes-Neto OM, Reichlin T, Salman RA, Shoamanesh A, Sposato LA, van der Worp HB, Kirchhof P, Thomalla G. Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE): protocol for an international investigator-initiated, prospective, randomised, open, blinded endpoint assessment (PROBE) interventional multi-centre trial. Eur Stroke J. 2026 May 6;11(5):aakag022. doi: 10.1093/esj/aakag022. |
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| Hotchkiss Brain Institute, University of Calgary | OTHER |
| Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht | UNKNOWN |
| UMC Utrecht | OTHER |
| Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh | UNKNOWN |
| Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre | UNKNOWN |
| CTC-NORTH | UNKNOWN |
| Stroke Alliance for Europe (SAFE) | UNKNOWN |
| Kompetenznetz Vorhofflimmern e.V. (AFNET) | UNKNOWN |
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| 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. |
|
| Time to first hospitalization due to worsening of heart failure | Hospitalization due to worsening of heart failure as recorded by study investigators | Through study completion, an average of 42 months |
| Time to hospitalization due to acute coronary syndrome | Hospitalization due to acute coronary syndrome as recorded by study investigators | Through study completion, an average of 42 months |
| Time to recurrent AF | Through study completion, an average of 42 months |
| Cardiovascular hospitalization | Cardiovascular hospitalization as recorded by study investigators | Through study completion, an average of 42 months |
| All-cause hospitalizations | All-cause hospitalizations as recorded by study investigators | Through study completion, an average of 42 months |
| Time in sinus rhythm | Through study completion, an average of 42 months |
| Functional status assessed by the modified Rankin Scale | Modified Ranking Scale ranging from 0 (no symptoms) to 6 (death) with lower values indicating better status | at 12 and 24 months |
| Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D) | The EQ-5D index will be calculated with higher values indicating better health state | at 12 and 24 months |
| Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) | The MoCA ranges for 0 to 30, with higher values indicating better cognitive function | at 12 and 24 months |
| Cost of therapy | Through study completion, an average of 42 months |
| Through study completion, an average of 42 months |
| Adverse events | Adverse events related to the study intervention with special emphasis on proarrhythmia and complications due to interventions | Through study completion, an average of 42 months |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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