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

NCT01583218 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7513

Last updated 2023-08-07

Study results available
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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

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

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2016-01-31

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583218 on ClinicalTrials.gov