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A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants

This study is currently recruiting participants.
Verified April 2017 by Portola Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02329327
First Posted: December 31, 2014
Last Update Posted: April 5, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Portola Pharmaceuticals
  Purpose
The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The safety of andexanet will also be studied.

Condition Intervention Phase
Bleeding Biological: Andexanet Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients with excellent or good hemostasis [ Time Frame: Stopping major bleed at 12 hours from the start of andexanet bolus ]

Estimated Enrollment: 350
Study Start Date: January 2015
Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Biological: Andexanet

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by at least one of the following:

    • Acute bleeding that is potentially life-threatening, OR
    • Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR
    • Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin is available, OR
    • Acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial.
  2. If bleeding is intracranial or intraspinal, the patient must have undergone a head CT or MRI scan demonstrating the bleeding.
  3. Patient received or is believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin.
  4. For patients with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.

Exclusion:

  1. The patient is scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures.
  2. A patient with an intracerebral hemorrhage has any of the following:

    • Glasgow coma score < 7, OR
    • Intracerebral hematoma > 60 cc as assessed by CT or MRI
  3. Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying bleed.
  4. Expected survival of less than 1 month
  5. Recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization or severe peripheral vascular disease within 2 weeks prior to screening.
  6. Severe sepsis or septic shock at the time of Screening.
  7. Pregnant or a lactating female.
  8. Patient has received any of the following drugs or blood products within 7 days of Screening:

    • Vitamin K antagonist (VKA)
    • Dabigatran
    • Prothrombin Complex Concentrate products (PCC) or recombinant factor VIIa (rfVIIa)
    • Whole blood, plasma fractions
  9. Treated with an investigational drug <30 days prior to Screening
  10. Planned administration of PCC, fresh frozen plasma (FFP) or rfVIIa from Screening until within 12 hours after the end of the andexanet infusion.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329327


Contacts
Contact: Patrick Yue, M.D. 650.246.7000 fXaantidote@portola.com

  Hide Study Locations
Locations
United States, California
Portola Investigational Site Recruiting
Long Beach, California, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Los Angeles, California, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Orange, California, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Florida
Portola Investigational Site Recruiting
Fort Lauderdale, Florida, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Jacksonville, Florida, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Sarasota, Florida, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Tampa, Florida, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Maryland
Portola Investigational Site Recruiting
Annapolis, Maryland, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Massachusetts
Portola Investigational Site Recruiting
Boston, Massachusetts, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Michigan
Portola Investigational Site Recruiting
Detroit, Michigan, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Royal Oak, Michigan, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Troy, Michigan, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Missouri
Portola Investigational Site Recruiting
Saint Louis, Missouri, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, New York
Portola Investigational Site Recruiting
Rochester, New York, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, North Carolina
Portola Investigational Site Recruiting
Asheville, North Carolina, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Chapel Hill, North Carolina, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Raleigh, North Carolina, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Ohio
Portola Investigational Site Recruiting
Cincinnati, Ohio, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Cleveland, Ohio, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Pennsylvania
Portola Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, Texas
Portola Investigational Site Recruiting
Austin, Texas, United States
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Fort Worth, Texas, United States
Contact    650-246-7000    fXaantidote@portola.com   
United States, West Virginia
Portola Investigational Site Recruiting
Huntington, West Virginia, United States
Contact    650-246-7000    fXaantidote@portola.com   
Belgium
Portola Investigational Site Recruiting
Bruxelles, Belgium
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Genk, Belgium
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Leuven, Belgium
Contact    650-246-7000    fXaantidote@portola.com   
Canada, Ontario
Portola Investigational Site Recruiting
Hamilton, Ontario, Canada
Contact    650.246.7000    fXaantidote@portola.com   
Canada, Quebec
Portola Investigational Site Recruiting
Montreal, Quebec, Canada
Contact    650-246-7000    fXaantidote@portola.com   
France
Portola Investigational Site Recruiting
Clermont-Ferrand, France
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Grenoble, France
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Limoges, France
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Lyon, France
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Poitiers, France
Contact    650-246-7000    fXaantidote@portola.com   
Germany
Portola Investigational Site Recruiting
Berlin, Germany
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Dresden, Germany
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Greifswald, Germany
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Hannover, Germany
Contact    650-246-7000    fXaantidote@portola.com   
Netherlands
Portola Investigational Site Recruiting
Amsterdam, Netherlands
Contact    650-246-7000    fXaantidote@portola.com   
Spain
Portola Investigational Site Recruiting
Barcelona, Spain
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Caceres, Spain
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Madrid, Spain
Contact    650-246-7000    fXaantidote@portola.com   
United Kingdom
Portola Investigational Site Recruiting
Cardiff, United Kingdom
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
London, United Kingdom
Contact    650-246-7000    fXaantidote@portola.com   
Portola Investigational Site Recruiting
Stoke on Trent, United Kingdom
Contact    650-246-7000    fXaantidote@portola.com   
Sponsors and Collaborators
Portola Pharmaceuticals
Population Health Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02329327     History of Changes
Other Study ID Numbers: 14-505
First Submitted: December 18, 2014
First Posted: December 31, 2014
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Portola Pharmaceuticals:
Factor Xa Inhibitors
Major
Bleeding
Anticoagulant

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action