EUCTR2013-003190-99-FR进行中（未招募）1 期
Evaluation of the use of an oral direct anti-Xa anticoagulant, Apixaban in prevention of venous thromboembolic disease in patients treated with IMiDs during myeloma: a pilot study - MYELAXAT
CHU de Grenoble0 个研究点开始时间: 2015年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients (men/women) aged more than 18 years
- •All consecutive patients, with myeloma, in first-line treatment or in relapse, who are treated
- •-With IMiDs (MPT, Melphalan -Prednisone -Thalidomide ; Lenalidomide - Dexamethasone).
- •-who require prevention of venous thromboembolic events with Aspirin or Low molecular Weight Heparin (LMWH) for a minimum duration of 6 months
- •At least, 2/3 of patients will be treated with Lenalidomide-Dexamethasone.
- •Written informed consent
- •Patients affiliated to the French social security system or equivalent
- •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 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Patient who needs curative anticoagulant treatment (heparin, LMWH, vitamin K antagonists, Dabigatran, Rivaroxaban, Apixaban) for an associated disorder (mechanical valve, atrial fibrillation or venous thromboembolic disease in the previous 6 months).
- •Patient who needs preventive treatment with an anticoagulant in a post-operative context
- •Patient who needs anti-platelet treatment (Aspirin, Clopidogrel, Prasugrel, Ticagrelor or dual anti-platelet therapy )
- •Patient with active bleeding or at a high risk of bleeding (ulcer disease, intracranial bleeding in the previous 6 months, uncontrolled hypertension)
- •Patient having undergone a surgical intervention within the past 30 days likely to expose them to an haemorrhagic risk
- •Active hepatic disease (hepatitis, cirrhosis)
- •Severe renal insufficiency (creatinine clearance using the Cockcroft equation < 30 ml/mn)
- •Known allergic reaction to Apixaban
- •Contraindication to the use of an anticoagulant treatment
- •Prohibited concomitant treatment
- •- inhibitors of CYP3A4 and P-gp : azole antimycotic agents (ketoconazole, itraconazole, voriconazole, posaconazole), inhibitors of HIV protease (ritonavir, indinavir, nelfinavir, atazanavir, saquinavir), specific macrolide antibiotics (clarithromycine, telithromycine)
- •- other antithrombotic treatment : salicylate derivates (aspirin, products containing aspirin), antiplatelet therapy, heparin (unfractionated heparin, low molecular weight heparin, danaparoide sodique, fondaparinux), hirudines, oral anticoagulants (vitamin K antagonists, rivaroxaban, dabigatran)
- •Patient with AST or ALT rate > 3 times upper limit of normal
- •Patient with Bilirubin rate > 1.5 times upper limit of normal
- •Patient with Platelets rate < 75 G/l
- •Patient with Creatinine Clearance (Cockcroft) < 30 ml/mn
- •Incidental finding of a proximal Deep Venous Thrombosis on the screening ultrasound
- •Patients refusing or unable to give a written consent of information
- •Patient unable to comply with the protocol requirement, in the investigator’s opinion
- •Life expectancy less than 6 months
- •Incarcerated patients
- •Pregnancy or possibility of pregnancy within 6 months
- •Females of childbearing potential without reliable contraception
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