CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 400 enrolled
Drug / intervention
Oral apixaban +1 moredrug
Likely dose
Oral apixaban 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02366871
NCT02366871Phase 2Completed
CompareCT.gov

The Safety of Oral Apixaban (Eliquis) Versus Subcutaneous Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy; a Prospective Randomized Open Blinded End-point (PROBE) Design

University of Colorado, Denver·interventional·Posted Feb 19, 2015·Updated Mar 31, 2020

In Brief

A Phase 2 clinical trial evaluating Oral apixaban and Subcutaneous enoxaparin for Gynecologic Cancer and Venous Thromboembolism. Completed, enrolled 400 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGynecologic Cancer, Venous Thromboembolism
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartApr 28, 2015
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.4 years ago

Interventions

Oral apixabandrug

To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.

Subcutaneous enoxaparindrug

To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.