Clinical trial NCT05293080: Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
Official title: Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Atrial Fibrillation
Keywords: Acute ischemic stroke
Atrial fibrillation
Rhythm control
Ablation
Antiarrhythmic drugs
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University Heart & Vascular Center Hamburg, Department of Cardiology
name: Department of Neurology, Royal Melbourne Hospital
name: Melbourne Heart Centre, Royal Melbourne Hospital
name: Hotchkiss Brain Institute, University of Calgary
name: Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht
name: UMC Utrecht
name: Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh
name: Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre
name: Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf
name: CTC-NORTH
name: Stroke Alliance for Europe (SAFE)
name: Kompetenznetz Vorhofflimmern e.V. (AFNET)
First posted: 2022-03-24
Enrollment: 1746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
timeFrame: Through study completion, an average of 42 months
Secondary outcomes:
measure: Time to first recurrent stroke
timeFrame: Through study completion, an average of 42 months
measure: Time to cardiovascular death
timeFrame: Through study completion, an average of 42 months
measure: Time to first hospitalization due to worsening of heart failure
timeFrame: Through study completion, an average of 42 months
measure: Time to hospitalization due to acute coronary syndrome
timeFrame: Through study completion, an average of 42 months
measure: Time to recurrent AF
timeFrame: Through study completion, an average of 42 months
measure: Cardiovascular hospitalization
timeFrame: Through study completion, an average of 42 months
measure: All-cause hospitalizations
timeFrame: Through study completion, an average of 42 months
measure: Time in sinus rhythm
timeFrame: Through study completion, an average of 42 months
measure: Functional status assessed by the modified Rankin Scale
timeFrame: at 12 and 24 months
measure: Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D)
timeFrame: at 12 and 24 months
measure: Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: at 12 and 24 months
measure: Cost of therapy
timeFrame: Through study completion, an average of 42 months
Other outcomes:
measure: All-cause mortality
timeFrame: Through study completion, an average of 42 months
measure: Severe bleeding complications
timeFrame: Through study completion, an average of 42 months
measure: Adverse events
timeFrame: Through study completion, an average of 42 months
Locations:
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Götz Thomalla, MD
role: PRINCIPAL_INVESTIGATOR
References: