NCT01583218

Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

(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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,513 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Venous Thromboembolism (VTE)

Interventions

Type	Name	Description
DRUG	Betrixaban	Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days
DRUG	Enoxaparin	Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days. Betrixaban Placebo: once daily, 35 days

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2012-04-23
• Last updated: 2023-08-07
• Results posted: 2017-09-20

Locations

462 sites across 34 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Montserrat, Peru, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Ukraine, United Kingdom