Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban … (NCT01094886) | Clinical Trial Compass
CompletedPhase 3
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
United States56 participantsStarted 2010-03
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)
Timeframe: Day 1, Day 3
2
Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time