ANNEXA-I: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

About this Study

The purpose of this study is to determine whether andexanet is better or worse than usual standard of care treatments (“usual care”) at treating the bleeding in the brain.  

Sponsor Protocol ID:18-513
IRB Number:2021-1011
Actively Enrolling
Phase 4
November 18, 2022
Eligibility Criteria
18 years old
89 years old
Both Male and Female

Inclusion Criteria
  • Written informed consent
  • Age 18 to 89
  • An acute intracerebral bleeding episode
  • CT or MRI scan demonstrating the intracerebral bleeding within 2 hours prior to randomization
  • Treatment with and oral FXa inhiibitor, rivaroxaban, or edoxaban
  • Time from bleeding symptom onset less than or equal to 6 hours prior to baseline imaging scan
  • Willingness to use medically acceptable methods of contraception through 30 day following study drug use
  • Negative pregnancy test

Exclusion Criteria
  • Planned surgery, including Burr holes for hematoma drainage, within 12 hours after randomization
  • Glasgow Coma Scale score less than 7
  • Any bleeding into epidural space
  • Anticipation that the baseline and follow up brain scans will not be able to use the same imaging modalities
  • Expected survival of less than 1 month
  • Recent history of a diagnosed TE or clinically relevant symptoms
  • Acute decompensated heart failure or cardiogenic shock at the time of randomization
  • Severe sepsis or septic shock at time of randomization
  • Pregnant or lactating female
  • Past use of andexanet
  • Treatment with an investigational drug less than 30 days prior to consent
  • Any tumor-relating bleeding
  • Known hypersensitivity of any component of andexanet
  • National Institutes of Health Stroke Scale (NIHSS) score greater than 35 at the time of consent

Categories Click category to view its trials.
Stroke/Traumatic Brain Injury
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Stephanie Moore
Phone Number: 601-496-7812
Principal Investigator:Nandi, Utsav, M.D.
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