NL-OMON50094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 - the Caravaggio study - Caravaggio
Fondazione FADOI Italian Federation of Hospital Internists0 个研究点目标入组 180 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •A newly diagnosed, objectively confirmed symptomatic or unsuspected, proximal
- •lower limb DVTor a symptomatic PE or an unsuspected PE in a segmental or more
- •proximal pulmonary artery. and any type of cancer (other than basal cell or
- •squamous cell carcinoma of the skin, primary brain tumors or intracerebral
- •metastasis and acute leukemia that meets at least one of the following: Active
- •cancer defined as diagnosis of cancer within 6 months before the study
- •inclusion, or receiving treatment for cancer at the time of inclusion or any
- •treatment for cancer during 6 months prior to randomization, or recurrent
- •locally advanced or metastatic cancer. Cancer diagnosed within 2 years before
- •the study inclusion (history of cancer).
排除标准
- •less than 18 years of age. ECOG performance status III or IV. Life expectancy
- •of less than 6 months. Related to anti coagulant therapy: administration of
- •therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for
- •more than 72 hours before randomization. Three 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 anti coagulant
- •treatment for a disease other than the index VTE. Concomitant use of strong
- •inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein. Related
- •to bleeding risks: concomitant thienopyridine therapy (clopidogrel, pasugrel or
- •ticagrelor) or aspirin over 165 mg daily oe dual antiplatlet therapy. Active
- •bleeding or a high risk of bleeding contraindicating anticoagulant therapy.
- •`recent (in the last 1 month prior to randomization) brain, spinal or
- •ophthalmic surgery. Hemoglobin level lower than 8 g/dl (5.0 mmil/Liter or
- •platelet count less than 75 x 10 to the 9th/L or history of heparin induced
- •thrombocytopenia. Creatinine clearance less than 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 of of the higher of the upper limit of the
- •normal range. uncontrolled hypertension (systolic BP more than 180 mm HG or
- •diastolic BP more than 100 mm Hg despite antihypertensive treatment. Standard
- •criteria: Bacterial endocarditis, hypersensitivity to the study drugs or to any
- •of their excipients, patients participating in other pharmacy therapeutic
- •program with an experimental therapy that is know to effect the coagulation
- •system, women of child bearing potential (WOCBP) who do not practice a
- •medically accepted high effective contraception during the trial and one months
- •beyond, pregnancy or breast feeding, any condition that is judged by the
- •investigator that would place the subject at increased risk or harm if (s)he
- •participated in the study.
研究者
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