Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Study Objective: To assess the value of Rivaroxaban for the prevention of venous
thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of
reference.
Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of
the type and duration of the procedure, will be eligible for the study.
Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two
arms:
- (R-7d) Rivaroxaban (10 mg od os) for 7 days
- (PL-7d) Placebo for 7 days.
Follow-up: 3-month period after the randomization
Standard of Reference:Placebo will be the standard of reference in accordance to
international guidelines
Study length May 2012-December 2012
Total patients number: 500 patients
Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at
least one of the following events, objectively proven (by means of CCDU; multi-slice chest
TC-angio; autopsy, if necessary, or clinical ground):
- All-cause mortality
- Symptomatic VTE
- Asymptomatic proximal DVT
Secondary Efficacy End-point:
• Combined incidence of all DVT plus symptomatic PE
Primary Safety End-point: Incidence of major bleedings.
Secondary Safety End-point: Overall incidence of bleeding