A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Safety Outcomes
研究概览
简要总结
Patients with cancer who develop stroke are at high risk for future strokes or other clotting events. These patients are routinely treated with medicines that thin their blood, including enoxaparin or aspirin. However, it is unclear which medicine is best and whether these medicines can be adequately studied in a clinical trial.
The purpose of this Phase I/II study is to determine if a clinical trial of different blood thinners in patients with cancer and stroke is possible. In addition, the study aims to compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with cancer and recent stroke.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years of age.
- •Active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months.
- •A pathology report issued at the enrolling site confirming the diagnosis of cancer is required for enrollment.
- •Acute ischemic stroke within the prior four weeks, defined as a new neurologic deficit(s) with MRI evidence of acute ischemia in a referable location, and no clinical or radiologic indication of a non-cerebrovascular mimic, such as a brain metastasis, as the etiology of the deficit(s).
排除标准
- •Inability to get brain MRI
- •Known malignant primary brain tumor.
- •Diagnosis of intracranial hemorrhage within the past 3 months, including intratumoral hemorrhage into brain metastases from a systemic cancer.
- •Active or serious bleeding within two weeks of enrollment.
- •Patient condition associated with a high risk of bleeding such as recent surgery or peptic ulcer disease.
- •Clear indication for anticoagulation (e.g., atrial fibrillation) anticipated during the study period.
- •Clear indication for antiplatelet agents (e.g., cardiac stents); a patient receiving aspirin for primary prevention prior to index stroke may be enrolled as long as study investigators believe it would be safe for the patient to stop aspirin if the patient was randomized to the enoxaparin arm.
- •Active bleeding diathesis.
- •Platelet count of ≤ 70,000/mm3, an international normalized ratio (INR) > 1.6, or a partial thromboplastin time (PTT) > 40 seconds.
- •Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia.
- •Serum creatinine > 2 mg/dl.
- •AST or ALT > 200 U/L.
- •Hemoglobin < 8 gm/dl
- •Symptomatic carotid stenosis.
- •Active pregnancy.
- •Life expectancy < 1 month or current hospice care
- •Unavailability for follow-up.
研究组 & 干预措施
Enoxaparin
Patients assigned to enoxaparin.
干预措施: Enoxaparin (Drug)
Aspirin
Patients assigned to Aspirin.
干预措施: Aspirin (Drug)
结局指标
主要结局
Safety Outcomes
时间窗: 1 year
Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death
Feasibility Outcomes
时间窗: 6 months
The primary feasibility outcome is patient enrollment defined as the number of patients who enroll in the study divided by the number of patients who were eligible to enroll.
次要结局
- Number of Participants With or Without Recurrent Ischemic Stroke(6 months)