Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01583218
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : September 20, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 16, 2012
First Posted Date  ICMJE April 23, 2012
Results First Submitted Date  ICMJE July 19, 2017
Results First Posted Date  ICMJE September 20, 2017
Last Update Posted Date September 26, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 [ Time Frame: mITT Cohort 1: Between randomization and Day 47 (max) ]
    mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
  • mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 [ Time Frame: mITT Cohort 2: Between randomization and Day 47 (max) ]
    mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
  • mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 [ Time Frame: mITT: Between randomization and Day 47 (max) ]
    mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
  • Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication [ Time Frame: Between randomization and Day 49 (max) ]
    Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Composite of VTE (DVT and/or PE) and VTE Death [ Time Frame: Occurrence of any of the events through the Day 35 visit ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 [ Time Frame: mITT Cohort 1: Between randomization and Day 42 (max) ]
    mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
  • mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 [ Time Frame: mITT Cohort 2: Between randomization and Day 42 (max) ]
    mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
  • mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 [ Time Frame: mITT: Between randomization and Day 42 (max) ]
    mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Official Title  ICMJE (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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism (VTE)
Intervention  ICMJE
  • Drug: Betrixaban

    Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.

    Enoxaparin Placebo: Once daily, 6-14 days

  • Drug: Enoxaparin

    Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.

    Betrixaban Placebo: once daily, 35 days

Study Arms  ICMJE
  • Experimental: Betrixaban
    Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
    Intervention: Drug: Betrixaban
  • Active Comparator: Enoxaparin
    Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
    Intervention: Drug: Enoxaparin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2017)
7513
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
6850
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Czechia,   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,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01583218
Other Study ID Numbers  ICMJE 11-019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Portola Pharmaceuticals
Study Sponsor  ICMJE Portola Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Portola Pharmaceuticals
Verification Date June 2016

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