ANNEXa-1 (18-513): 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 intracerebral hemorrhage within 6 hours of symptom onset (from the baseline scan) and within 15 hours of taking an oral FXa inhibitor (from randomization). The study will use a prospective, randomized, open-label design, as it is unfeasible to blind the Investigator to the treatment assignment given the many potential therapeutic options available under usual care treatment. The primary efficacy outcome will be adjudicated by a blinded Endpoint Adjudication Committee (EAC). 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 study.
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