Phase 2 Completed N=241 Randomized Double-blind Prevention

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

Venous Thromboembolism · Haemorrhage

Source: ClinicalTrials.gov NCT01629381 ↗

Enrolled (actual)

241

Serious AEs

0.0%

Results posted

May 2021

Primary outcomePrimary: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality — 1; 7 participants — p=0.03

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality	1; 7	0.03 sig
PRIMARY Major Bleedings	0; 0	—
SECONDARY Combined Incidence of All DVT Plus Symptomatic PE	8; 2	0.03 sig
SECONDARY Overall Incidence of Bleeding	6; 4	0.53

Eligibility Criteria

Inclusion Criteria

Adult patient (18 years and older)
Knee arthroscopy not combined with open surgery.
Patients eligible for surgical treatment.
Patients are willing and able to continue study participation to ensure completion of all procedures and observations required by the study.
Written informed consent

Exclusion Criteria

Diagnostic arthroscopy
Patients concomitantly treated systemically with strong concurrent CYP3A4 and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors.
Hypersensitivity to the active substance or to any of the excipients of study drug
Pregnant women or breast-feeding.
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Known thrombophilia (hereditary or acquired)
Mandatory anticoagulation.
Known severe bleeding tendency
Clinically significant active bleeding.
Severe renal failure (GFR<30mL/min/1.73m2)
Patients participating in another clinical trial.
Recent mayor surgery (6 to 12 weeks)

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Data sourced from ClinicalTrials.gov (NCT01629381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.