A study in which patients hospitalized for non-major orthopaedic surgery and requiring treatment to prevent blood clots in legs due to immobilization may be assigned randomly to receive either Rivaroxaban caps or Enoxaparin injections to compare the efficacy and safety of the 2 treatments.
- Conditions
- Venous Thromboembolism ProphylaxisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-000981-70-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4400
1. Signed and dated informed consent form,
2. Age = 18 years,
3. Hospitalised for non-major orthopaedic surgery and requiring thromboprophylaxis according to the investigator’s judgement on VTE risk such Achilles’ repair, knee, 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
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: foot surgery (Hallux Valgus), material removal, Anterior Cruciate Ligament with less than 15 days of immobilization or before weight bearing
4.Time between hospitalisation and surgery greater than 36 hours,
5.More than one injection of LMWH since the end of surgery
6.Women of childbearing potential not using a reliable contraceptive method throughout the study period (a list of reliable contraceptive methods is provided in the accompanying SPM),
7.Women pregnant or breast-feeding during the study period,
8.Body weight less than 50 kg (to avoid bleeding over risk) or over 120 kg,
9.Treatment with VKA therapy or DOAs,
10.Concomitant treatment with clopidogrel, prasugrel and ticagrelor,
11.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
12.Platelet count < 100 Giga/L,
13.Documented history of acquired or inherited bleeding disorder (e.g., von Willebrand's disease),
14.Severe renal failure with calculated creatinine clearance (Cockcroft Formula) < 30 mL/min,
15.Severe hepatic insufficiency with prothrombin time < 60% or liver impairment associated with coagulation disorders,
16.History of heparin induced thrombocytopenia,
17.Any other current significant medical condition that might interfere with treatment evaluation according to the investigator’s judgement,
18.Known hypersensitivity or other severe reaction to any component of the investigational medicinal product(s),
19.Participation in another clinical study involving an investigational medicinal product within 30 days prior to inclusion or concomitantly with this study,
20.Active bleeding or contraindication to anticoagulant therapy
21.Chronic alcoholic intoxication,
22.Anticipated poor compliance of subject with study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method