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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
December 18, 2014
December 31, 2014
April 5, 2017
January 2015
November 2022   (Final data collection date for primary outcome measure)
Proportion of patients with excellent or good hemostasis [ Time Frame: Stopping major bleed at 12 hours from the start of andexanet bolus ]
Proportion of patients with excellent or good hemostasis [ Time Frame: Stopping major bleed at 24 hours from the start of andexanet bolus ]
Complete list of historical versions of study NCT02329327 on ClinicalTrials.gov Archive Site
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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
Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Bleeding
Biological: Andexanet
Experimental: Single Arm
Intervention: Biological: Andexanet
Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2016 Sep 22;375(12):1131-41. doi: 10.1056/NEJMoa1607887. Epub 2016 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
Not Provided
November 2022   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Patrick Yue, M.D. 650.246.7000 fXaantidote@portola.com
Belgium,   Canada,   France,   Germany,   Netherlands,   Spain,   United Kingdom,   United States
 
 
NCT02329327
14-505
Yes
Not Provided
Not Provided
Portola Pharmaceuticals
Portola Pharmaceuticals
Population Health Research Institute
Not Provided
Portola Pharmaceuticals
April 2017

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