NCT03045406已完成3 期
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Fadoi Foundation, Italy127 个研究点 分布在 6 个国家目标入组 1,170 人开始时间: 2017年4月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,170
- 试验地点
- 127
- 主要终点
- Recurrent Venous Thromboembolism
研究概览
简要总结
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery;
- •Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia);
- •Signed and dated informed consent of the patient, available before the start of any specific trial procedure.
排除标准
- •age <18 years;
- •ECOG Performance Status III or IV;
- •life expectancy of less than 6 months;
- •Related to anticoagulant treatment:
- •administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
- •3 or more doses of a vitamin K antagonist before randomization;
- •thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
- •indication for anticoagulant treatment for a disease other than the index VTE episode;
- •Related to bleeding risk:
- •thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
- •active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;
- •recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
- •hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or history of heparin induced thrombocytopenia;
- •creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;
- •acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range;
- •uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite antihypertensive treatment);
- •concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein;
- •Standard criteria:
- •bacterial endocarditis;
- •hypersensitivity to the active substance or to any of the excipients of study drug;
- •patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;
- •childbearing potential without proper contraceptive measures, pregnancy, or breast feeding;
- •any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
研究组 & 干预措施
Apixaban
Experimental
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
干预措施: Apixaban (Drug)
Dalteparin
Active Comparator
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
干预措施: Dalteparin (Drug)
结局指标
主要结局
Recurrent Venous Thromboembolism
时间窗: 6 months
Primary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of: · proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected)
次要结局
未报告次要终点
研究者
研究点 (127)
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