Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet versus
usual standard of care in patients with intracranial hemorrhage anticoagulated with a direct
This is a randomized, multicenter clinical trial designed to determine the efficacy and
safety of andexanet compared to usual care in patients presenting with acute intracranial
hemorrhage within 6 hours of symptom onset and within 15 hours of taking an oral factor Xa
inhibitor. The study will use a prospective, randomized, open label (PROBE) design. The
primary efficacy outcome will be adjudicated by a blinded Endpoint Adjudication Committee. To
support the adjudication of hemostatic efficacy, a blinded Imaging Core Laboratory will
review all available scans. Approximately 900 patients are planned to be enrolled in the
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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