Last updated on July 2019

Trial of Andexanet in ICH Patients Receiving an Oral FXa Inhibitor


Brief description of study

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 oral anticoagulant

Detailed Study Description

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 12 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 440 patients are planned to be enrolled in the study.

Clinical Study Identifier: NCT03661528

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Holy Cross Hospital

Fort Lauderdale, FL United States
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Anne Arundel Medical Center

Annapolis, MD United States
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Beaumont Hospital - Royal Oak

Royal Oak, MI United States
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Dell Seton Medical Center

Austin, TX United States
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Recruitment Status: Open


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