Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients|
- Composite of VTE (DVT and/or PE) and VTE Death [ Time Frame: Occurrence of any of the events through the Day 35 visit ] [ Designated as safety issue: No ]
- Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Betrixaban 80 mg PO QD for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days
|Active Comparator: Enoxaparin||
Enoxaparin 40 mg SC QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 days