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andexxa, Coagulation Factor Xa (Recombinant), Inactivated-zhzo
申请企业
Portola Pharamceuticals
药品名称
andexxa, Coagulation Factor Xa (Recombinant), Inactivated-zhzo
承诺描述
Study-18-513: “A Phase 4 randomized trial of ANDEXXA in acute intracranial hemorrhage in patients receiving oral factor Xa inhibitors”: This open-label, randomized trial will include at least 440 adult patients who developed acute intracranial hemorrhage following the treatment with rivaroxaban, apixaban, or edoxaban 15 hours or less prior to randomization. The enrolled patients will be administered ANDEXXA (high or low dose) or standard of care other than ANDEXXA according to 1:1 randomization scheme. To describe and verify the hemostatic effect of ANDEXXA, patients will be assessed with the National Institute of Health Stroke Scale and computed tomography or magnetic resonance imaging at 12-hours post- randomization. The trial assessments will also include evaluation of occurrence of the safety events of special interest, including but not limited to: stroke, transient ischemic event, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, arterial systemic embolism, sudden death, and events suspicious for thrombosis, embolism, and ischemia—all to be observed at least 3 days for immediate occurrence and at least 30 days with weekly intervals for delayed occurrence. The assessments of the hemostatic effect will be made by an adjudication committee blinded to the treatment allocation.