Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
- Conditions
- Acute Ischemic StrokeAtrial Fibrillation
- Registration Number
- NCT05293080
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1746
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to cardiovascular death Through study completion, an average of 42 months All-cause hospitalizations Through study completion, an average of 42 months All-cause hospitalizations as recorded by study investigators
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
Time to recurrent AF Through study completion, an average of 42 months 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
Time to first recurrent stroke Through study completion, an average of 42 months Recurrent stroke 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
Cardiovascular hospitalization Through study completion, an average of 42 months Cardiovascular hospitalization as recorded by study investigators
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 in sinus rhythm Through study completion, an average of 42 months Cost of therapy Through study completion, an average of 42 months