Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- D-dimer change
研究概览
简要总结
Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.
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
- None
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
- •Adults over 20 years old
- •Acute cerebral infarction within 30 days of symptom onset was confirmed by diffusion-weighted brain magnetic resonance imaging (DWI)
- •Cancer-related stroke, not diagnosed with other classic (arteriosclerosis, cardioembolicm, small-vessel occlusion, etc.) cerebral infarction, within six months of diagnosis, chemotherapy, surgery for cancer.
- •with informed consent from the patient or next-of-kin, When the subject becomes able to decide whether to participate in the study, the researcher acquires further consent directly from the subject.
排除标准
- •Patients with primary intracranial malignancy
- •Patients with classic causes of cerebral infarction
- •Patients with infectious or immunological disease that may affect blood D-dimer levels
- •Patients whose cerebral infarction is thought to be caused by tumor (vascular occlusion due to tumor tissue)
- •Patients who can not use anticoagulants with thrombocytopenia (platelet <50,000), anemia (hemoglobin <8)
- •Decreased renal function (creatine clearance <15 mL / mim)
- •Patients who received intravenous tissue plasminogen activator
- •Patients with uncontrolled severe hypertension
- •Patients who received prosthetic heart valve replacement requiring anticoagulation
- •Patients with moderate to severe mitral stenosis
- •Pulmonary embolism requiring hemodynamically unstable or thrombolysis or pulmonary embolization
- •Pregnant and lactating women
- •Patients who are hypersensitive to the major component or constituent of the test drug
- •Patients with liver diseases associated with blood clotting disorders and clinically significant bleeding risks
研究组 & 干预措施
Edoxaban group
Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days.
干预措施: Edoxaban (Drug)
Enoxaparin group
Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
D-dimer change
时间窗: 7 days after treatment
interval change of serum D-dimer level between day 0 and 7
次要结局
- Surrogate endpoint(7 days after treatment)
- Functional outcome(90 days after enrollment)
- Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage](90 days after enrollment)
研究者
Oh Young Bang
Professor
Samsung Medical Center