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NCT02366871 · ClinicalTrials.gov registry record · Phase 2
Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy
A Phase 2 study of Gynecologic Cancer and Venous Thromboembolism, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 2
- Study locations
NCT02366871: Completed Phase 2 study of Gynecologic Cancer and Venous Thromboembolism, sponsored by University of Colorado, Denver.
NCT02366871 is a Phase 2 study of Gynecologic Cancer and Venous Thromboembolism that has completed, run by University of Colorado, Denver. The registered enrollment target is 400 participants, below the 757-participant average among 55 other Gynecologic Cancer trials with a reported enrollment target (47% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02366871, a Phase 2 study of Gynecologic Cancer and Venous Thromboembolism, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study will evaluate the incidence of major bleeding (including clinically relevant non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous enoxaparin 40 mg once a day (QD) for 28 days post surgery.
Primary Outcome
The International Society on Thrombosis and Hemostasis criteria (ISTH) will be used to assess incidence of major bleeding. Participants were monitored for up to 90 days. This is the number of participants who have had at least one major bleeding incidence during the time of observation.
Conditions Studied
Interventions
- DRUG Oral apixaban
- DRUG Subcutaneous enoxaparin
Study Locations (2)
California
- University of Southern California Keck School of Medicine - Los Angeles
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2015-04-28 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
What the finished NCT02366871 record still lists
NCT02366871 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 757-participant average among 55 other Gynecologic Cancer trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Gynecologic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Oral apixaban is the first listed.
NCT02366871 reports a single indexed study location in California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02366871 about?
NCT02366871 is a clinical study titled "Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy". The study will evaluate the incidence of major bleeding (including clinically relevant non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous enoxaparin 40 mg once a day (QD) for 2...
What is the current status of trial NCT02366871?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2015-04-28. Estimated completion is 2019-06.
What conditions does trial NCT02366871 study?
This clinical trial studies the following conditions: Gynecologic Cancer, Venous Thromboembolism.
What interventions are being tested in trial NCT02366871?
The interventions under investigation include: Oral apixaban (DRUG), Subcutaneous enoxaparin (DRUG).
Who is sponsoring clinical trial NCT02366871?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02366871 being conducted?
This trial has 2 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gynecologic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02366871's enrollment target sits among peer trials
400 10th of 55 higher than 46 of 55 other Gynecologic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gynecologic Cancer 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.
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