A Prospective, Multicenter, Randomized Controlled Trial of Anticoagulation Therapy After Ischemic Stroke in Patients With Previous Intracerebral Hemorrhage and Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 852
研究概览
简要总结
This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years.
- •Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT).
- •Documented history of spontaneous intracerebral hemorrhage (ICH).
- •Confirmed non-valvular atrial fibrillation (including paroxysmal, persistent, or permanent subtypes).
- •Provision of written informed consent by the patient or a legally authorized representative.
排除标准
- •Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score >
- •Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
- •Severe, uncontrolled hypertension refractory to medical therapy.
- •Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) < 30 mL/min.
- •Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
- •Documented contraindications to direct oral anticoagulants according to the product summary of characteristics (excluding the previous spontaneous ICH), including but not limited to hypersensitivity, active clinically significant bleeding, high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- •Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
- •Estimated life expectancy of less than 1 year due to concomitant terminal illness.
研究者
Min Lou
Dr.
Second Affiliated Hospital, School of Medicine, Zhejiang University