Acute Ischemic Stroke, Atrial Fibrillation
Conditions
Keywords
Acute ischemic stroke, Atrial fibrillation, Rhythm control, Ablation, Antiarrhythmic drugs
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
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.
Interventions
OTHERMedical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
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.
OTHERUsual care for atrial fibrillation
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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
University Heart & Vascular Center Hamburg, Department of Cardiology
Department of Neurology, Royal Melbourne Hospital
Melbourne Heart Centre, Royal Melbourne Hospital
Hotchkiss Brain Institute, University of Calgary
Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht
UMC Utrecht
Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh
Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre
CTC-NORTH
Stroke Alliance for Europe (SAFE)
Kompetenznetz Vorhofflimmern e.V. (AFNET)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome. | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrent stroke | Through study completion, an average of 42 months | Recurrent stroke as recorded by study investigators |
| 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 | Hospitalization due to worsening of heart failure as recorded by study investigators |
| Time to hospitalization due to acute coronary syndrome | Through study completion, an average of 42 months | Hospitalization due to acute coronary syndrome as recorded by study investigators |
| Time to recurrent AF | Through study completion, an average of 42 months | — |
| Cardiovascular hospitalization | Through study completion, an average of 42 months | Cardiovascular hospitalization as recorded by study investigators |
| All-cause hospitalizations | Through study completion, an average of 42 months | All-cause hospitalizations as recorded by study investigators |
| Time in sinus rhythm | Through study completion, an average of 42 months | — |
| Functional status assessed by the modified Rankin Scale | at 12 and 24 months | Modified Ranking Scale ranging from 0 (no symptoms) to 6 (death) with lower values indicating better status |
| Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D) | at 12 and 24 months | The EQ-5D index will be calculated with higher values indicating better health state |
| Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) | at 12 and 24 months | The MoCA ranges for 0 to 30, with higher values indicating better cognitive function |
| Cost of therapy | Through study completion, an average of 42 months | — |
Countries
Germany
Contacts
CONTACTMärit Jensen, MD
CONTACTGötz Thomalla, MD
PRINCIPAL_INVESTIGATORGötz Thomalla, MD
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed