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The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study.

Publication ,  Journal Article
Cohen, AT; Harrington, R; Goldhaber, SZ; Hull, R; Gibson, CM; Hernandez, AF; Kitt, MM; Lorenz, TJ
Published in: Am Heart J
March 2014

Randomized clinical trials have identified a population of acute medically ill patients who remain at risk for venous thromboembolism (VTE) beyond the standard duration of therapy and hospital discharge. The aim of the APEX study is to determine whether extended administration of oral betrixaban (35-42 days) is superior to a standard short course of prophylaxis with subcutaneous enoxaparin (10 ± 4 days followed by placebo) in patients with known risk factors for post-discharge VTE. Patients initially are randomized to receive either betrixaban or enoxaparin (and matching placebo) in a double dummy design. Following a standard duration period of enoxaparin treatment (with placebo tablets) or betrixaban (with placebo injections), patients receive only betrixaban (or alternative matching placebo). Patients are considered for enrollment if they are older than 40 years, have a specified medical illness, and restricted mobility. They must also meet the APEX criteria for increased VTE risk (aged ≥75 years, baseline D-Dimer ≥2× upper the limit of "normal", or 2 additional ancillary risk factors for VTE). The primary efficacy end point is the composite of asymptomatic proximal deep venous thrombosis, symptomatic deep venous thrombosis, non-fatal (pulmonary embolus) pulmonary embolism, or VTE-related death through day 35. The primary safety outcome is the occurrence of major bleeding. We hypothesize that extended duration betrixaban VTE prophylaxis will be safe and more effective than standard short duration enoxaparin in preventing VTE in acute medically ill patients with known risk factors for post hospital discharge VTE.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

March 2014

Volume

167

Issue

3

Start / End Page

335 / 341

Location

United States

Related Subject Headings

  • Venous Thromboembolism
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Pyridines
  • Prospective Studies
  • Middle Aged
  • Internationality
  • Humans
  • Factor Xa Inhibitors
 

Citation

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Cohen, A. T., Harrington, R., Goldhaber, S. Z., Hull, R., Gibson, C. M., Hernandez, A. F., … Lorenz, T. J. (2014). The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J, 167(3), 335–341. https://doi.org/10.1016/j.ahj.2013.11.006
Cohen, Alexander T., Robert Harrington, Samuel Z. Goldhaber, Russell Hull, C Michael Gibson, Adrian F. Hernandez, Michael M. Kitt, and Todd J. Lorenz. “The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study.Am Heart J 167, no. 3 (March 2014): 335–41. https://doi.org/10.1016/j.ahj.2013.11.006.
Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, et al. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335–41.
Cohen, Alexander T., et al. “The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study.Am Heart J, vol. 167, no. 3, Mar. 2014, pp. 335–41. Pubmed, doi:10.1016/j.ahj.2013.11.006.
Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335–341.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

March 2014

Volume

167

Issue

3

Start / End Page

335 / 341

Location

United States

Related Subject Headings

  • Venous Thromboembolism
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Pyridines
  • Prospective Studies
  • Middle Aged
  • Internationality
  • Humans
  • Factor Xa Inhibitors