At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 530 enrolled
Drug / intervention
andexanet alfa +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor
In Brief
A Phase 4 clinical trial evaluating andexanet alfa and Usual Care for Acute Intracranial Hemorrhage. Completed, enrolled 530 participants across 142 sites in 24 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Intracranial Hemorrhage
CountriesAustria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartJun 2019
Primary CompletionMay 2023
Study CompletionAug 2023
TodayJul 2026
First PostedSep 7, 2018
Enrollment StartJun 6, 2019
Primary CompletionMay 27, 2023
Study CompletionAug 9, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.8 years ago
Interventions
andexanet alfadrug
Andexanet alfa is a recombinant version of human FXa
Usual Caredrug
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.