Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,746
- 试验地点
- 1
- 主要终点
- Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Early rhythm control therapy
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.
干预措施: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version) (Other)
Usual care
Patients with acute ischemic stroke and AF will receive usual care following the current ESC guidelines for AF treatment.
干预措施: Usual care for atrial fibrillation (Other)
结局指标
主要结局
Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
时间窗: 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
次要结局
- Time to cardiovascular death(Through study completion, an average of 42 months)
- All-cause hospitalizations(Through study completion, an average of 42 months)
- Functional status assessed by the modified Rankin Scale(at 12 and 24 months)
- 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)
- Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)(at 12 and 24 months)
- Time to first recurrent stroke(Through study completion, an average of 42 months)
- Time to hospitalization due to acute coronary syndrome(Through study completion, an average of 42 months)
- Cardiovascular hospitalization(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)
- Time in sinus rhythm(Through study completion, an average of 42 months)
- Cost of therapy(Through study completion, an average of 42 months)