Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF (OASIS-AF)
2026年5月20日 更新者：Min Lou、Second Affiliated Hospital, School of Medicine, Zhejiang University
A Prospective, Multicenter, Randomized Controlled Trial of Anticoagulation Therapy After Ischemic Stroke in Patients With Previous Intracerebral Hemorrhage and Atrial Fibrillation
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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
852
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Min Lou, PhD, MD
- 电话号码：8613958007213
- 邮箱：lm99@zju.edu.cn
研究联系人备份
- 姓名：Wansi Zhong, MD
- 电话号码：8618757155806
- 邮箱：21718233@zju.edu.cn
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score > 4.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Anticoagulation Therapy
Participants in this arm will receive early initiation of direct oral anticoagulants (DOACs) following an individualized clinical assessment.
Initiation is contingent upon the exclusion of hemorrhagic transformation via head CT/SWI within 24 hours prior to treatment.
|
Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
|
|
有源比较器：Non-Anticoagulation Therapy
Participants will not receive oral anticoagulation therapy during the study period.
Patients may be prescribed single antiplatelet therapy (e.g., aspirin or clopidogrel) or no antithrombotic therapy, strictly at the discretion of the treating physician based on current clinical guidelines and individual patient risk profiles.
|
Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of the Composite Endpoint of Recurrent Stroke
大体时间：Up to 12 months
|
Proportion of participants experiencing a recurrent ischemic stroke or a recurrent intracerebral hemorrhage (ICH).
Events will be adjudicated by independent, blinded clinical assessors.
|
Up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Recurrent Ischemic Stroke
大体时间：Up to 12 months.
|
Proportion of participants experiencing a recurrent acute ischemic stroke.
|
Up to 12 months.
|
|
Incidence of Recurrent Intracerebral Hemorrhage (ICH)
大体时间：Up to 12 months.
|
Proportion of participants experiencing a recurrent spontaneous ICH.
|
Up to 12 months.
|
|
Time to First Occurrence of Recurrent Ischemic Stroke
大体时间：Up to 12 months
|
Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke.
|
Up to 12 months
|
|
Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH)
大体时间：Up to 12 months
|
Time interval from randomization to the confirmed diagnosis of a recurrent ICH.
|
Up to 12 months
|
|
Incidence of Vascular Death
大体时间：Up to 12 months
|
Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction).
|
Up to 12 months
|
|
All-Cause Mortality Rate
大体时间：Up to 12 months
|
Proportion of participants who die from any cause during the follow-up period.
|
Up to 12 months
|
|
Incidence of Major Bleeding Events
大体时间：Up to 12 months
|
Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.
|
Up to 12 months
|
|
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding
大体时间：Up to 12 months
|
Proportion of participants experiencing bleeding events that do not meet the ISTH criteria for major bleeding but result in medical intervention, hospitalization, or discontinuation of the study drug.
|
Up to 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Min Lou, PhD, MD、Second Affiliated Hospital, School of Medicine, Zhejiang University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2029年6月1日
研究完成 (估计的)
2029年9月1日
研究注册日期
首次提交
2026年5月20日
首先提交符合 QC 标准的
2026年5月20日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月20日
最后验证
2026年5月1日
更多信息
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