Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement
Condition: Arthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Thromboembolism
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Thromboembolism
Intervention: Rivaroxaban
Intervention description: 10mg tablet daily, receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Total Hip Replacement; Total Knee Replacement; Hip Implant; Knee Implant; Joint Prosthesis; Orthopedic Surgery; Rivaroxaban; Xarelto; Blood Clot

Summary:

      The study will describe the short-term effects the study drug, rivaroxaban, has on the body
      when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by
      mouth) for the prevention of blood clotting in the veins after elective total hip or total
      knee replacement surgery. After providing written informed consent, screening procedures will
      be completed to assess eligibility. After enrollment, all patients will be switched from
      enoxaparin to rivaroxaban. Blood samples for the short-term effects of rivaroxaban will be
      taken at various times while in the subacute unit. At the time of discharge, if the study
      doctor feels it is appropriate, an adequate supply of rivaroxaban will be provided to
      complete the full course of therapy. Upon completion of rivaroxaban therapy, all patients
      will be required to have final study procedures performed. Safety evaluations at the final
      visit will include clinical blood laboratory tests, a physical examination, urine pregnancy
      test (if applicable), recording of any adverse events including details regarding any
      bleeding episodes or blood clot events, and assessment of the surgical wound. All patients
      will return any unused study medication and study participation will be complete.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergone elective total hip or knee replacement surgery

          -  Received postoperative venous blood clot prevention therapy within 24 hours of the
             surgery

          -  Currently prescribed enoxaparin 30mg subcutaneous (SQ) twice a day or 40mg SQ daily
             for venous blood clotting prevention with an expected duration of continued prevention
             therapy of at least 3 days after admission to a subacute unit

          -  Discharged from the hospital to a subacute unit (including skilled nursing facilities
             and rehabilitation units) and committed to remaining in the unit for the duration of
             the Pharmacodynamic blood sampling period of the study

        Exclusion Criteria:

          -  Platelet count <90,000/µL based on screening laboratory assessments

          -  active internal bleeding or high risk of bleeding

          -  history of, or condition associated with, increased bleeding risk including

          -  planned invasive procedure with potential for uncontrolled bleeding, including major
             surgery

          -  sustained uncontrolled high blood pressure, defined as systolic blood pressure =180
             mmHg or diastolic blood pressure =100 mmHg

          -  clinically significant kidney disease and/or impaired kidney function

          -  clinically significant liver disease

          -  anemia

          -  known allergies, hypersensitivity, or intolerance to rivaroxaban

          -  indication for anticoagulant (blood thinning) therapy for a condition other than blood
             clot prevention

          -  anticipated need for treatment with a prescription or nonprescription non-steroidal
             anti-inflammatory drugs (NSAIDs)

          -  any patient who has taken more than one or two doses of aspirin (>100 mg/dose) in the
             week prior to enrollment will not be allowed to participate

          -  Drug addiction or alcohol abuse within 3 years prior to screening