EUCTR2016-003093-40-IT进行中（未招募）1 期
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study - Caravaggio
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) 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.
- •2) Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or known intracerebral metastases and acute leukemia) that meets at least one of the following:
- •Active cancer defined as diagnosis of cancer within six 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).
- •3) Signed and dated informed consent, available before the start of any specific trial procedure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 818
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •1) Age <18 years
- •2) ECOG Performance Status III or IV;
- •3) Life expectancy of less than 6 months;
- •Related to anticoagulant treatment:
- •4) Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
- •5) 3 or more doses of a vitamin K antagonist before randomization;
- •6) Thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
- •7) Iindication for anticoagulant treatment for a disease other than the index VTE episode;
- •8) Concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein (see Appendix 1);
- •Related to bleeding risk:
- •9) Concomitant thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
- •10) Active bleeding or high risk of bleeding contraindicating anticoagulant treatment
- •11) Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
- •12) Hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x109/L or history of heparin-induced thrombocytopenia;
- •13) Creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;
- •14) 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;
- •15) Uncontrolled hypertension (systolic BP> 180 mm Hg or diastolic BP > 100 mm Hg despite antihypertensive treatment);
- •Standard criteria:
- •16) Bacterial endocarditis;
- •17) Hypersensitivity to the study drugs or to any of their excipients;
- •18) Patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system.
- •19) Women of childbearing potential (WOCBP) who do not practice a medically accepted highly effective contraception during the trial and one month beyond. Highly effective contraception methods are:
- •a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- •b. progestogen-only hormonal contraception associated with inhibition of ovulation
- •c. intrauterine device (IUD)
- •d. intrauterine hormone-releasing system (IUS)
- •e. bilateral tubal occlusion
- •f. vasectomized partner
- •g. sexual abstinence ;
- •20) Pregnancy, or breast feeding
- •21) Any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study.
研究者
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