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PSNResearch is proud to have managed this International Trial in Nonmajor Orthopaedic Surgery
Last week was announced the final publication of one of our most valuables Trials supported at ACC.20 World Congress of Cardiology. The hard work of all the SITES involved, PIs, PATIENTS and PSNResearch (CRO in charge of managing The Clinical Trial in ALL country), it is now been rewarded with these great results.
Last week was announced the final publication of one of our most valuables Trials supported at ACC.20 World Congress of Cardiology. The hard work of all the SITES involved, PIs, PATIENTS and PSNResearch (CRO in charge of managing The Clinical Trial in ALL country), it is now been rewarded with these great results.
“From PSNResearch, we would like to THANK all the Team involved in this TRIAL, as it was an example of Collaboration and Support during these years”
GENERAL INFO OF THE TRIAL
WHAT WAS THE GOAL?
The goal of the trial was to evaluate rivaroxaban (Xarelto™) compared with enoxaparin in preventing major venous thromboembolism among patients immobilized after lower limb nonmajor orthopaedic surgery.
WHERE HAS BEEN DONE?
▪ 10 countries and 200 sites were covered by PSNResearch Company as CRO responsible to coordinate the achievement of these successful results.
▪ France, Germany, Netherlands, Spain, Italy, Greece, Hungary, Czech Republic, Poland, Tunisia were the 10 countries involved.
▪ Only in Spain, PSNResearch Spain was coordinating and monitoring 40 sites enrolled in this Trial.
HOW MANY PATIENTS INCLUDED?
- A total of 3604 patients underwent randomization
- 1809 patients were assigned to receive rivaroxaban
- 1795 patients to receive enoxaparin
- Main Inclusion criteria: Adults undergoing nonmajor orthopaedic surgery of the lower limbs and requiring thromboprophylaxis for >2 weeks (investigator’s assessment).
WHAT ARE THE PRINCIPAL FINDINGS?
- PRIMARY OUTCOMES
- The primary efficacy outcome of major venous thromboembolism (VTE), defined as symptomatic distal or proximal deep vein thrombosis (DVT), pulmonary embolism, or VTE-related death during the treatment period, or asymptomatic proximal DVT at the end of treatment, occurred in 0.2% of the rivaroxaban group compared with 1.1% of the enoxaparin group (risk ratio with multiple imputation,0.25; 95% confidence interval [CI], 0.09 to 0.75; P
- The primary safety outcome of major and nonmajor clinically relevant bleeding occurred in 1.1% of the rivaroxaban group compared with 1.0% of the enoxaparin group and did not differ significantly (p = 0.62).
- SECONDARY OUTCOMES
- Net clinical benefit: 0.8% of the rivaroxaban group compared with 1.8% of the enoxaparin group.
- This data from the clinical phase III trial PRONOMOS, was presented as part of a virtual Late-Breaking Clinical Trial Session of the American College of Cardiology’s 69th Annual Scientific Session together with World Congress of Cardiology (ACC.20/WCC Virtual) and published simultaneously in The New England Journal of Medicine.
