A Prospective Observational Cohort Study Evaluating the Effectiveness and Safety of Antiplatelet and Anticoagulant Therapies in Patients With Active Cancer and Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Recurrent Stroke
研究概览
简要总结
The goal of this observational study is to learn about the effectiveness and safety of antiplatelet and anticoagulant treatments in people with a history of cancer who have acute ischemic stroke. The main questions it aims to answer are:
- Are there differences in the risk of another stroke between people receiving antiplatelet treatment and those receiving anticoagulant treatment?
- Are there differences in the risk of bleeding between the treatment groups?
- Which clinical characteristics, imaging findings, cancer-related factors, and blood test results are associated with treatment outcomes?
Participants will:
- Receive antiplatelet treatment, anticoagulant treatment, or a combination of both, as selected by their treating physicians during routine clinical care.
- Provide clinical information and blood samples for the study.
- Complete follow-up assessments approximately 30, 90, 180, and 360 days after the stroke.
Researchers will compare recurrent stroke, bleeding, other blood clot-related events, functional recovery, and survival among participants receiving different antithrombotic treatments. The study will not assign or change participants' treatments.
详细描述
The goal of this prospective observational study is to learn about the effectiveness and safety of different antithrombotic treatments in adults with a history of cancer and acute ischemic stroke. The main questions it aims to answer are:
- Are there differences in the risk of recurrent stroke among patients receiving antiplatelet therapy, anticoagulant therapy, or combined therapy?
- Are there differences among the treatment groups in the risk of symptomatic intracranial hemorrhage and major extracranial bleeding?
- Are there differences among the treatment groups in the occurrence of systemic arterial embolism, venous thromboembolism, acute myocardial infarction, disability, and death?
- Which clinical characteristics, stroke mechanisms, neuroimaging findings, cancer-related factors, and laboratory measurements are associated with treatment selection and clinical outcomes?
Participants will:
- Be enrolled within 7 days after the onset of acute ischemic stroke or the last known well time.
- Receive antiplatelet therapy, anticoagulant therapy, or combined therapy as selected by their treating physicians during routine clinical care.
- Provide demographic, clinical, imaging, cancer-related, treatment-related, and laboratory information.
- Provide blood samples for coagulation, platelet, inflammatory, hematologic, biochemical, and other planned assessments.
- Complete follow-up assessments approximately 30, 90, 180, and 360 days after the index stroke.
Researchers will compare the effectiveness and safety outcomes of patients receiving different antithrombotic treatments. The primary effectiveness outcome will be recurrent stroke. The primary safety outcomes will be symptomatic intracranial hemorrhage and major extracranial bleeding. Other outcomes will include systemic arterial embolism, venous thromboembolism, acute myocardial infarction, functional status measured using the modified Rankin Scale, and all-cause mortality.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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 or older.
- Diagnosis of acute ischemic stroke confirmed by clinical evaluation and brain imaging.
- Enrollment within 7 days after symptom onset or the time the participant was last known to be well.
- History of a malignant tumor, regardless of whether the cancer is currently active or inactive.
- Written informed consent provided by the participant or the participant's legally authorized representative.
排除标准
- Hematologic malignancy.
- Primary intracerebral hemorrhage, subarachnoid hemorrhage, or another non-ischemic type of stroke.
- Transient ischemic attack without evidence of acute ischemic stroke.
- Pregnancy or breastfeeding.
- Known severe congenital coagulation disorder.
- Collection of research blood samples would delay intravenous thrombolysis, mechanical thrombectomy, or other necessary treatment.
- Blood samples that do not meet the prespecified collection requirements or show severe hemolysis.
- Inability to obtain reliable medical history or outcome information from the participant, medical records, or an authorized representative.
研究组 & 干预措施
Antiplatelet Therapy Group
Patients with acute ischemic stroke and a history of cancer who receive antiplatelet therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol.
Anticoagulant Therapy Group
Patients with acute ischemic stroke and a history of cancer who receive anticoagulant therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol.
Combined Antiplatelet and Anticoagulant Therapy Group
Patients with acute ischemic stroke and a history of cancer who receive combined antiplatelet and anticoagulant therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol.
结局指标
主要结局
Number of Participants With Recurrent Stroke
时间窗: 30 days, 90 days, 180 days, and 360 days after enrollment
Recurrent stroke is defined as a new acute neurological deficit consistent with ischemic or hemorrhagic stroke occurring after enrollment and confirmed by clinical evaluation and brain imaging. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Number of Participants With Symptomatic Intracranial Hemorrhage
时间窗: 30 days, 90 days, 180 days, and 360 days after enrollment
Symptomatic intracranial hemorrhage is defined as a newly detected intracranial hemorrhage on brain imaging that is associated with neurological deterioration or other clinically relevant symptoms. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Number of Participants With Major Extracranial Bleeding
时间窗: 30 days, 90 days, 180 days, and 360 days after enrollment
Major extracranial bleeding includes clinically significant bleeding outside the cranial cavity that results in death, occurs in a critical organ or site, requires blood transfusion, or causes a clinically significant decrease in hemoglobin. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
次要结局
- Number of Participants With Systemic Arterial Embolism(30 days, 90 days, 180 days, and 360 days after enrollment)
- Number of Participants With Venous Thromboembolism(30 days, 90 days, 180 days, and 360 days after enrollment)
- Number of Participants With Myocardial Infarction(30 days, 90 days, 180 days, and 360 days after enrollment)
- Number of Participants Who Die From Any Cause(30 days, 90 days, 180 days, and 360 days after enrollment)
- Functional Outcome Measured by the Modified Rankin Scale(30 days, 90 days, 180 days, and 360 days after enrollment)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07845903
- 其他研究编号
- hongyanl2
日期
- 首次提交
- (17天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否