Trial record 1 of 2 for:    VTE 11-019
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Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

This study is currently recruiting participants. (see Contacts and Locations)
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: September 24, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism (VTE)
Drug: Betrixaban
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: (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

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 6850
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Betrixaban Drug: Betrixaban

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

Enoxaparin Placebo: Once daily, 6-14 days

Active Comparator: Enoxaparin Drug: Enoxaparin

Enoxaparin 40 mg SC QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days


  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583218

Contacts
Contact: APEX Study Clinical Trial Contact 650-246-7361 ApexClinicalStudy@Portola.com

  Show 471 Study Locations
Sponsors and Collaborators
Portola Pharmaceuticals
  More Information

No publications provided by Portola Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01583218     History of Changes
Other Study ID Numbers: 11-019
Study First Received: April 16, 2012
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Phase III

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014