NCT03661528

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Acute Intracranial Hemorrhage

Interventions

Type	Name	Description
DRUG	andexanet alfa	Andexanet alfa is a recombinant version of human FXa
DRUG	Usual Care	Usual care will consist of any treatment(s) (including no treatment) other than andexanet alfa administered within 3 hours post-randomization that the Investigator and/or other treating physicians consider to be appropriate.

Timeline

• Start date: 2019-06-06
• Primary completion: 2023-05-27
• Completion: 2023-08-09
• First posted: 2018-09-07
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

142 sites across 24 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study