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

NCT03661528 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2024-07-03

Study results available
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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

Conditions

  • Acute Intracranial Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2023-05-27
Completion
2023-08-09
FDA Drug
Yes

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661528 on ClinicalTrials.gov