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NCT01094886 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT01094886: Completed Phase 3 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
NCT01094886 is a Phase 3 study that has completed, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01094886, a Phase 3 study, has completed, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Rivaroxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT01094886 record still lists
NCT01094886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Rivaroxaban is the first listed.
NCT01094886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01094886 about?
NCT01094886 is a clinical study titled "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". 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. Af...
What is the current status of trial NCT01094886?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2010-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01094886?
The interventions under investigation include: Rivaroxaban (DRUG).
Who is sponsoring clinical trial NCT01094886?
This trial is sponsored by Ortho-McNeil Janssen Scientific Affairs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01094886's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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