Last updated on August 2020

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 6 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 900 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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Beaumont Health

Troy, MI United States
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St.George's Hospital

London, United Kingdom
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Salford Royal Hospital

Salford, United Kingdom
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Nottingham City Hospital

Nottingham, United Kingdom
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Ohio State University

Columbus, OH United States
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Marshall Health

Huntington, WV United States
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RH N-KLINIKUM Campus Bad Neustadt

Bad Neustadt An Der Saale, Germany
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Addenbrooke's Hospital

Cambridge, United Kingdom
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Leicester Royal Infirmary

Leicester, United Kingdom
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The Royal Victoria Infirmary

Newcastle Upon Tyne, United Kingdom
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Sacred Heart Hospital

Pensacola, FL United States
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Tampa General Hospital

Tampa, FL United States
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Ascension St. John Hospital

Detroit, MI United States
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Royal Columbian Hospital

New Westminster, BC Canada
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Foch Hospital

Suresnes, France
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RH N-KLINIKUM Campus Bad Neustadt

Bad Neustadt An Der Saale, Germany
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Isala Hospital

Zwolle, Netherlands
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Recruitment Status: Open


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