Optimal Anticoagulation Strategy In Stroke Related to CANCER (OASIS-CANCER Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Recurrent stroke or systemic embolism
研究概览
简要总结
Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of cancer-related stroke, particularly in those without conventional stroke etiologies. Randomized clinical trials have investigated efficacy of vitamin K-dependent oral anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However, relatively little is known about the biological changes underlying intravascular coagulopathy and mechanisms of anticoagulation therapy in patients with cancer-related stroke. The aim of this study is to evaluate to determine the biological markers for intravascular coagulopathy causing stroke and for monitoring the effects of anticoagulation therapy, in patients with active cancer and stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years and older
- •Acute ischemic stroke presented within 7 days of symptom onset
- •Cancer related stroke: active cancer (diagnosis of cancer within 6 months of stroke onset, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer) and ischemic stroke which could not be explained by conventional stroke mechanisms including large artery atherosclerosis, cardioembolism, lacunar infarction, or other etiologies (e.g., dissection)
- •Signed informed consent or appropriate signed deferral of consent where approved
排除标准
- •Primary intracranial malignancy
- •Incomplete workup for stroke etiology (either vascular or cardiologic studies)
- •Any signs of infectious or immunological diseases which may influence plasma D-dimer levels
- •Patients with stroke suspected to be caused by the tumor itself (i.e., tumor emboli) or cancer treatment (i.e., chemotherapy-induced stroke)
结局指标
主要结局
Recurrent stroke or systemic embolism
时间窗: up to 6 months
Recurrent stroke (development of neurologic deterioration or a new symptom/sign and relevant new cerebral lesions documented by a neuroimaging study) or systemic embolism (objectively documented, symptomatic, recurrent deep-vein thrombosis, pulmonary embolism, or both ).
次要结局
- 90-days modified Rankin Scale score(examined at 90 days after stroke symptom onset in each patients)
- Symptomatic hemorrhagic transformation(up to 6 months)
- Effect of anticoagulation treatment(up to 14 days)