Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
440

Summary

Conditions
Acute Intracranial Hemorrhage
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 89 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03661528
Collaborators
Population Health Research Institute
Investigators
Not Provided