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

Portola Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism (VTE)

Treatments: Drug: Betrixaban; Drug: Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583218

11-019

Details and patient eligibility

About

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.

Enrollment: 7,513 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,513 participants in 2 patient groups

Betrixaban

Experimental group

Description:

Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days

Treatment:

Drug: Betrixaban

Enoxaparin

Active Comparator group

Description:

Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days

Treatment:

Drug: Enoxaparin