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
- Conditions
- flebitispreventie diepe veneuze trombosevenous thromboembolism
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
1. Signed and dated informed consent form,
2. Age * 18 years,
3. Hospitalised for non-major orthopaedic surgery of the lower limbs and requiringthromboprophylaxis 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.
1. Major orthopaedic surgery of the lower limbs: 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 (i.e. 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 (a list of reliable contraceptive methods is provided),
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint, major venous thromboembolic events (VTE), is a<br /><br>composite endpoint which includes proximal (asymptomatic and symptomatic) deep<br /><br>vein thromboses (DVT), symptomatic events (distal and proximal DVTs, pulmonary<br /><br>embolisms) and VTE-related deaths up until the end of the treatment period.</p><br>
- Secondary Outcome Measures
Name Time Method