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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,746
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 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.
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGTime 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
Time frame: Through study completion, an average of 42 months
Time to first recurrent stroke
Recurrent stroke as recorded by study investigators
Time frame: Through study completion, an average of 42 months
Time to cardiovascular death
Time frame: Through study completion, an average of 42 months
Time to first hospitalization due to worsening of heart failure
Hospitalization due to worsening of heart failure as recorded by study investigators
Time frame: 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
Time frame: Through study completion, an average of 42 months
Time to recurrent AF
Time frame: Through study completion, an average of 42 months
Cardiovascular hospitalization
Cardiovascular hospitalization as recorded by study investigators
Time frame: Through study completion, an average of 42 months
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All-cause hospitalizations
All-cause hospitalizations as recorded by study investigators
Time frame: Through study completion, an average of 42 months
Time in sinus rhythm
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 12 and 24 months
Cost of therapy
Time frame: Through study completion, an average of 42 months