Timing of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation: a Prospective Multicenter Registry-based Non-inferiority Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 888
- 试验地点
- 38
- 主要终点
- Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality
研究概览
简要总结
This study will compare early with late start of treatment with Non-vitamin K oral anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation; it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset) while the other half will start late (5-10 days after stroke onset).
详细描述
Oral anticoagulation therapy is well established and highly recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation, but the optimal time point to start after an acute ischemic stroke is not known.
The intervention in this study will be timing of treatment onset. The choice of NOAC (i.e. apixaban, dabigatran, edoxaban or rivaroxaban) after the acute ischemic stroke is at the discretion of the treating physician.
This study will use the Swedish Stroke Register for enrolment, randomization and follow-up, with additional data linkage from other mandatory national registers. Primary outcome will be assessed at 90 days and secondary outcomes (including all-cause mortality and health economic analyses) and will be assessed at 90 days and up to one year after the index ischemic stroke.
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
- •Adult patients (≥ 18 years) with acute ischemic stroke and atrial fibrillation
- •Eligible and willing to start (or re-start) NOAC
- •Registered in The Swedish Stroke Register
- •Signed informed consent
排除标准
- •Contraindication to NOAC (e.g. ongoing bleeding, mechanical heart valve prosthesis)
- •Ongoing therapy with NOAC (without ≥2 days interruption at index stroke)
- •International normalized ratio (INR)>1.7
- •No second brain imaging (CT/MRI) after thrombolysis/thrombectomy
- •Previous randomization in the TIMING study
结局指标
主要结局
Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality
时间窗: 90 days
次要结局
- Recurrent acute ischemic stroke(90 days)
- Symptomatic intracerebral hemorrhage (S-ICH)(90 days)
- All-cause mortality(90 days)
- Functional outcome(90 days)
- Major hemorrhages(90 days)