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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: June 17, 2013
Last verified: June 2013
History of Changes
  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:

U.S. FDA Resources

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: December 2014
Estimated Primary Completion Date: August 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583218

Contacts
Contact: APEX Study Clinical Trial Contact 855-256-7070 ApexClinicalStudy@Portola.com

  Show 227 Study Locations
Sponsors and Collaborators
Portola Pharmaceuticals
  More Information

No publications provided

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: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Phase III

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013