Trial record 1 of 1 for:    VTE 11-019
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified June 2013 by Portola Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01583218
First received: April 16, 2012
Last updated: February 11, 2014
Last verified: June 2013

April 16, 2012
February 11, 2014
March 2012
June 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01583218 on ClinicalTrials.gov Archive Site
Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ] [ Designated as safety issue: No ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6850
September 2015
June 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
Both
40 Years and older
No
Contact: APEX Study Clinical Trial Contact 855-256-7070 ApexClinicalStudy@Portola.com
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Peru,   Poland,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Ukraine,   United Kingdom
 
NCT01583218
11-019
Yes
Portola Pharmaceuticals
Portola Pharmaceuticals
Not Provided
Not Provided
Portola Pharmaceuticals
June 2013

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