Phase 3
Completed N=53
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
Arthritis · Osteoarthritis, Knee · Osteoarthritis, Hip · Thromboembolism
Source: ClinicalTrials.gov NCT01094886 ↗
Enrolled (actual)
53
Serious AEs
5.7%
Results posted
Feb 2012
Primary outcomePrimary: Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa) — 1.66; 1.83 IU/ml — p=.008
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa) |
1.66; 1.83 | .008 sig |
| PRIMARY Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time |
21.57; 20.51 | 0.111 |
| SECONDARY Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa |
21.35; 20.74 | 0.87 |
| SECONDARY Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time |
420.46; 391.37 | <0.001 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT01094886). 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.