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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

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ClinicalTrials.gov Identifier: NCT02329327
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Portola Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Bleeding Biological: Andexanet Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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)
Study Start Date : January 2015
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Arm Biological: Andexanet



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 ClinicalTrials@portola.com

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Locations
United States, California
Portola Investigational Site Completed
Long Beach, California, United States
Portola Investigational Site Completed
Los Angeles, California, United States
Portola Investigational Site Completed
Orange, California, United States
United States, Florida
Portola Investigational Site Completed
Fort Lauderdale, Florida, United States
Portola Investigational Site Completed
Jacksonville, Florida, United States
Portola Investigational Site Completed
Sarasota, Florida, United States
Portola Investigational Site Completed
Tampa, Florida, United States
United States, Maryland
Portola Investigational Site Completed
Annapolis, Maryland, United States
United States, Massachusetts
Portola Investigational Site Completed
Boston, Massachusetts, United States
United States, Michigan
Portola Investigational Site Completed
Detroit, Michigan, United States
Portola Investigational Site Completed
Royal Oak, Michigan, United States
Portola Investigational Site Completed
Troy, Michigan, United States
United States, Missouri
Portola Investigational Site Completed
Saint Louis, Missouri, United States
United States, New York
Portola Investigational Site Completed
Rochester, New York, United States
United States, North Carolina
Portola Investigational Site Completed
Asheville, North Carolina, United States
Portola Investigational Site Completed
Chapel Hill, North Carolina, United States
Portola Investigational Site Completed
Raleigh, North Carolina, United States
United States, Ohio
Portola Investigational Site Completed
Cincinnati, Ohio, United States
Portola Investigational Site Completed
Cleveland, Ohio, United States
United States, Pennsylvania
Portola Investigational Site Completed
Pittsburgh, Pennsylvania, United States
United States, Texas
Portola Investigational Site Completed
Austin, Texas, United States
Portola Investigational Site Completed
Fort Worth, Texas, United States
United States, West Virginia
Portola Investigational Site Completed
Huntington, West Virginia, United States
Belgium
Portola Investigational Site Completed
Bruxelles, Belgium
Portola Investigational Site Completed
Genk, Belgium
Portola Investigational Site Completed
Leuven, Belgium
Canada, Ontario
Portola Investigational Site Completed
Hamilton, Ontario, Canada
Canada, Quebec
Portola Investigational Site Completed
Montreal, Quebec, Canada
France
Portola Investigational Site Completed
Clermont-Ferrand, France
Portola Investigational Site Completed
Grenoble, France
Portola Investigational Site Completed
Limoges, France
Portola Investigational Site Completed
Lyon, France
Portola Investigational Site Completed
Poitiers, France
Germany
Portola Investigational Site Recruiting
Altenburg, Germany
Contact    650-246-7000      
Portola Investigational Site Recruiting
Augsburg, Germany
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Portola Investigational Site Recruiting
Berlin, Germany
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Portola Investigational Site Recruiting
Bremen, Germany
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Portola Investigational Site Recruiting
Celle, Germany
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Portola Investigational Site Recruiting
Chemnitz, Germany
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Portola Investigational Site Recruiting
Coburg, Germany
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Portola Investigational Site Recruiting
Detmold, Germany
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Portola Investigational Site Recruiting
Dresden, Germany
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Portola Investigational Site Recruiting
Essen, Germany
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Portola Investigational Site Recruiting
Greifswald, Germany
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Portola Investigational Site Recruiting
Göttingen, Germany
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Portola Investigational Site Recruiting
Hamburg, Germany
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Portola Investigational Site Recruiting
Hannover, Germany
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Portola Investigational Site Recruiting
Heidelberg, Germany
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Portola Investigational Site Recruiting
Hessen, Germany
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Portola Investigational Site Recruiting
Konstanz, Germany
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Portola Investigational Site Recruiting
Leipzig, Germany
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Portola Investigational Site Recruiting
Lubeck, Germany
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Portola Investigational Site Recruiting
Ludwigshafen, Germany
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Portola Investigational Site Recruiting
Mainz, Germany
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Portola Investigational Sitee Recruiting
Minden, Germany
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Portola Investigational Site Recruiting
Munich, Germany
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Portola Investigational Site Recruiting
Münster, Germany
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Portola Investigational Site Recruiting
Osnabrück, Germany
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Portola Investigational Site Recruiting
Regensburg, Germany
Contact    650-246-7000    fxaantidote@portola.com   
Portola Investigational Site Recruiting
Sande, Germany
Contact    650-246-7000    fxaantidote@portola.com   
Portola Investigational Site Recruiting
Trier, Germany
Contact    650-246-7000    fxaantidote@portola.com   
Portola Investigational Site Recruiting
Tübingen, Germany
Contact    650-246-7000    fxaantidote@portola.com   
Portola Investigational Site Recruiting
Ulm, Germany
Contact    650-246-7000    fxaantidote@portola.com   
Portola Investigational Site Recruiting
Würzburg, Germany
Contact    650-246-7000      
Netherlands
Portola Investigational Site Completed
Amsterdam, Netherlands
Spain
Portola Investigational Site Completed
Barcelona, Spain
Portola Investigational Site Completed
Caceres, Spain
Portola Investigational Site Completed
Madrid, Spain
United Kingdom
Portola Investigational Site Completed
Cardiff, United Kingdom
Portola Investigational Site Completed
London, United Kingdom
Portola Investigational Site Completed
Stoke on Trent, United Kingdom
Sponsors and Collaborators
Portola Pharmaceuticals
Population Health Research Institute

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 Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: May 2018

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