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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Collaborator: Bayer
• Treatments: Rivaroxaban

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