We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT02329327
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single Arm Biological: Andexanet


Outcome Measures

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 ]

Eligibility Criteria

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

  Show 44 Study Locations
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 Posted: December 31, 2014    Key Record Dates
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