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A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor XA Inhibitor

This is a randomized clinical trial 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).The primary objective is to evaluate the effect of andexanet versus usual care on the rate of effective hemostasis.

Open and enrolling subjects.
Phoenix, Arizona
Total Participants
Primary Sponsor
Portola Pharmaceutical, Inc.