Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy
Condition: Venous Thromboembolism; Haemorrhage
MeSH terms: Thromboembolism; Venous Thromboembolism; Hemorrhage
Intervention: Rivaroxaban; placebo
Intervention description: 10 mg os once daily for 1 week; 10 mg os once daily for 1 week
Intervention MeSH terms: Rivaroxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: knee arthroscopy; venous thromboembolism; prevention

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient (18 years and older)

          2. Knee arthroscopy not combined with open surgery.

          3. Patients eligible for surgical treatment.

          4. Patients are willing and able to continue study participation to ensure completion of
             all procedures and observations required by the study.

          5. Written informed consent

        Exclusion Criteria:

          1. Diagnostic arthroscopy

          2. Patients concomitantly treated systemically with strong concurrent CYP3A4 and
             P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors.

          3. Hypersensitivity to the active substance or to any of the excipients of study drug

          4. Pregnant women or breast-feeding.

          5. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk

          6. Known thrombophilia (hereditary or acquired)

          7. Mandatory anticoagulation.

          8. Known severe bleeding tendency

          9. Clinically significant active bleeding.

         10. Severe renal failure (GFR<30mL/min/1.73m2)

         11. Patients participating in another clinical trial.

         12. Recent mayor surgery (6 to 12 weeks)