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

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ClinicalTrials.gov Identifier: NCT02329327
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)
Population Health Research Institute
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

Condition or disease Intervention/treatment Phase
Bleeding Biological: Andexanet Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: N/A
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)
Actual Study Start Date : April 10, 2015
Actual Primary Completion Date : September 24, 2020
Actual Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Andexanet
Participants received andexanet as an intravenous bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
Biological: Andexanet
There were 2 possible dosing regimens: Low dose = 400 milligram (mg) bolus plus 4 mg/minute continuous infusion for 120 minutes; High dose = 800 mg bolus plus 8 mg/minute continuous infusion for 120 minutes.
Other Names:
  • ALXN2070
  • Andexanet Alfa
  • PRT064445
  • Andexxa




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

Key Inclusion Criteria:

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

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

Key Exclusion Criteria:

  1. The participant was scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures.
  2. Participant with an intracerebral hemorrhage that had any of the following:

    • Glasgow coma score <7, or
    • Intracerebral hematoma >60 cubic centimeters as assessed by CT or MRI
  3. Participants 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 as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation, 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. Participant received any of the following drugs or blood products within 7 days of Screening:

    • Vitamin K antagonist
    • Dabigatran
    • Prothrombin Complex Concentrate (PCC) products 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 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


Locations
Show Show 87 study locations
Sponsors and Collaborators
Alexion Pharmaceuticals
Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)
Population Health Research Institute
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02329327    
Other Study ID Numbers: 14-505
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals:
Factor Xa Inhibitors
Major Bleeding
Anticoagulant
Andexanet Alfa
Reversal Agent
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes