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
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ClinicalTrials.gov Identifier: NCT01094886 |
Recruitment Status :
Completed
First Posted : March 29, 2010
Results First Posted : February 27, 2012
Last Update Posted : March 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthritis Osteoarthritis, Knee Osteoarthritis, Hip Thromboembolism | Drug: Rivaroxaban | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Open-Label Study of the Transition to Rivaroxaban From Low-Molecular Weight Heparin for Venous Thromboembolism Prophylaxis After Total Joint Replacement: The Safe Simple Transitions Study |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
Rivaroxaban 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
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Drug: Rivaroxaban
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 |
- Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa) [ Time Frame: Day 1, Day 3 ]Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3
- Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time [ Time Frame: Day 1, Day 3 ]Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3
- Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa [ Time Frame: Day 1, Day 3 ]Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose
- Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time [ Time Frame: Day 1, Day 3 ]Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094886
United States, Colorado | |
Denver, Colorado, United States | |
United States, Florida | |
Hollywood, Florida, United States | |
Tamarac, Florida, United States | |
Vero Beach, Florida, United States | |
United States, New York | |
Glen Cove, New York, United States |
Study Director: | Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial | Ortho-McNeil Janssen Scientific Affairs, LLC |
Responsible Party: | Ortho-McNeil Janssen Scientific Affairs, LLC |
ClinicalTrials.gov Identifier: | NCT01094886 |
Other Study ID Numbers: |
CR016531 RIVAROXCPK3001 ( Other Identifier: Ortho-McNeil Janssen Scientific Affairs, LLC ) |
First Posted: | March 29, 2010 Key Record Dates |
Results First Posted: | February 27, 2012 |
Last Update Posted: | March 17, 2017 |
Last Verified: | February 2017 |
Total Hip Replacement Total Knee Replacement Hip Implant Knee Implant Joint Prosthesis |
Orthopedic Surgery Rivaroxaban Xarelto Blood Clot |
Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Thromboembolism Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Rivaroxaban Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |