EUCTR2015-000981-70-CZ进行中（未招募）1 期
A multicentre, randomised, double-blind, controlled, phase IIIb study to assess the efficacy and safety of Rivaroxaban 10mg od versus Enoxaparin 4000 IU for VTE PROphylaxis in NOn Major Orthopaedic Surgery. The PRONOMOS study - PRONOMOS
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
- 4,400
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. Signed and dated informed consent form,
- •2. Age = 18 years,
- •3. Hospitalised for non-major orthopaedic surgery of the lower limbs and requiring thromboprophylaxis according to the investigator’s judgement on VTE risk such Achilles’ repair, knee (including unicompartmental knee prosthesis), tibial plateau, femur (non femoral head), tibial and ankle fractures and tibial osteotomy, tibial transposition, arthrodesis of leg articulation, ligament repair of the knee with a planned immobilisation or partial weight-bearing for more than 2 weeks, ligament repair of the ankle or any elective orthopaedic limb surgery requiring thromboprophylaxis).
- •4. An intended duration of treatment for at least 2 weeks.
- •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 3400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •1.Major orthopaedic surgery: Hip and Knee replacement, femoral neck and trochanteric fractures, spine surgery,
- •2.Polytrauma (each lesion being individually life-threatening) or any life-threatening lesions,
- •3.Low risk surgery without patient VTE risk: Forefoot surgery (Hallux Valgus), material removal, Meniscectomy, Knee arthroscopy (except for ligament repair), Meniscal suture, Diagnostic arthroscopy
- •4.Time between hospitalisation and surgery greater than 48 hours,
- •5.More than one injection of LMWH since the end of surgery
- •6.More than two injections of LMWH before surgery
- •7.Women of childbearing potential not using a reliable contraceptive method throughout the study period. Reliable contraceptive methods are defined as the following: hormonal contraception (per os / implant / transdermal / injectable), intrauterine device (with or without hormone), condom (male or female), tubal ligation, partner’s vasectomy, sexual abstinence
- •8.Women pregnant or breast-feeding during the study period,
- •9.Body weight less than 50 kg (to avoid bleeding over risk) or over 120 kg,
- •10.Concomitant treatment with VKA therapy or DOAs,
- •11.Concomitant treatment with clopidogrel, prasugrel and ticagrelor,
- •12.Concomitant use of strong inhibitors of both CYP3A4 and P-gp, i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole.
- •13.Platelet count < 100 Giga/L,
- •14.Documented history of acquired or inherited bleeding disorder (e.g., von Willebrand's disease),
- •15.Severe renal failure with calculated creatinine clearance (Cockcroft Formula) < 30 mL/min,
- •16.Severe hepatic insufficiency with prothrombin time < 60% or liver impairment associated with coagulation disorders,
- •17.History of heparin induced thrombocytopenia,
- •18.Any other current significant medical condition that might interfere with treatment evaluation according to the investigator’s judgement,
- •19.Known hypersensitivity or other severe reaction to any component of the investigational medicinal product(s),
- •20.Participation in another clinical study involving an investigational medicinal product within 30 days prior to inclusion or concomitantly with this study,
- •21.Active bleeding or contraindication to anticoagulant therapy
- •22.Chronic alcoholic intoxication (cirrhotic patient),
- •23.Anticipated poor compliance of subject with study procedures
研究者
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