Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa
versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral
or indirect subcutaneous/intravenous anticoagulant
This is a randomized, multicenter clinical trial designed to determine the efficacy and
safety of andexanet alfa compared to usual care in patients presenting with acute
intracranial hemorrhage within 6 hours of symptom onset to baseline scan 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. Between 900 and 1200 patients are planned to
be enrolled in the study.
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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