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Trial record 1 of 1 for:    VTE 11-019
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Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) (APEX)

This study has been completed.
Information provided by (Responsible Party):
Portola Pharmaceuticals Identifier:
First received: April 16, 2012
Last updated: June 21, 2016
Last verified: June 2016

April 16, 2012
June 21, 2016
March 2012
December 2015   (Final data collection date for primary outcome measure)
Composite of VTE (DVT and/or PE) and VTE Death [ Time Frame: Occurrence of any of the events through the Day 35 visit ]
Same as current
Complete list of historical versions of study NCT01583218 on Archive Site
Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Venous Thromboembolism (VTE)
  • Drug: Betrixaban

    Betrixaban 80 mg PO QD for 35 day + 7 days.

    Enoxaparin Placebo: Once daily, 6-14 days

  • Drug: Enoxaparin

    Enoxaparin 40 mg SC QD for 10 ± 4 days.

    Betrixaban Placebo: once daily, 35 days

  • Experimental: Betrixaban
    Intervention: Drug: Betrixaban
  • Active Comparator: Enoxaparin
    Intervention: Drug: Enoxaparin

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Montserrat,   Peru,   Poland,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom
Not Provided
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Not Provided
Portola Pharmaceuticals
Portola Pharmaceuticals
Not Provided
Not Provided
Portola Pharmaceuticals
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP