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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Portola Pharmaceuticals
• Treatments: Betrixaban; Enoxaparin

Criteria

Inclusion Criteria:

• men and non-pregnant, non-breastfeeding women

• anticipated to be severely immobilized for at least 24 hours after randomization

• hospitalized with one of the following

• congestive heart failure

• acute respiratory failure,

• acute infection without septic shock,

• acute rheumatic disorders

• acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

• a condition requiring prolonged anticoagulation or anti-platelets

• active bleeding or at high risk of bleeding

• contraindication to anticoagulant therapy

• general conditions in which subjects are not suitable to participate in the study