Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

Acute Intracranial Hemorrhage Clinical Trial

Official title: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

Status Completed

Clinical Trial Summary

Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

Clinical Trial Description

This is a randomized, multicenter clinical trial designed to determine the efficacy and safety of andexanet alfa compared to usual care in patients presenting with acute intracranial hemorrhage within 6 hours of symptom onset to baseline scan 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. Between 900 and 1200 patients are planned to be enrolled in the study. ;

Related Conditions & MeSH terms

• Acute Intracranial Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages

• NCT number: NCT03661528
• Study type: Interventional
• Source: Alexion Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: June 6, 2019
• Completion date: August 9, 2023