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NCT00371683 · ClinicalTrials.gov registry record · Phase 3
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,608
- Enrollment target
NCT00371683: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00371683 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 3,608 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (367% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00371683, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,608 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
Primary Outcome
An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery
Interventions
- DRUG Enoxaparin + Placebo
- DRUG Apixaban + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,608 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00371683 record still lists
NCT00371683 is an interventional study that assigns participants to a tested intervention. Its 3,608 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (367% higher).
The record links to 0 conditions, and to 2 interventions - of which Enoxaparin + Placebo is the first listed.
NCT00371683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00371683 about?
NCT00371683 is a clinical study titled "Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery". The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The saf...
What is the current status of trial NCT00371683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,608 participants. The study started on 2006-11. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00371683?
The interventions under investigation include: Enoxaparin + Placebo (DRUG), Apixaban + Placebo (DRUG).
Who is sponsoring clinical trial NCT00371683?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00371683's enrollment target sits among peer trials
3,608 68th of 2000 higher than 1,933 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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