andexanet alfa for Brain Hemorrhage

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Brain Hemorrhage+2 More
andexanet alfa - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether andexanet alfa is effective and safe in treating patients with intracranial hemorrhage who are taking a direct oral or indirect subcutaneous/intravenous anticoagulant.

Eligible Conditions
  • Brain Hemorrhage
  • Acute Coryza

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Brain Hemorrhage

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 24 hours

1-2 hours
Change from baseline in anti-fXa activity
To evaluate the effect of andexanet versus usual care on anti-fXa activity.
12 hours
Proportion of patients with good or excellent hemostatic efficacy as rated by an independent adjudication committee
Hemostatic function
24 hours
Change from baseline in GCS
Change from baseline in NIHSS
Proportion of neurological deterioration, as defined by NIHSS increase > 4 or GCS decrease > 2

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Brain Hemorrhage

Trial Design

1 Treatment Group

andexanet alfa
1 of 1
Experimental Treatment

1200 Total Participants · 1 Treatment Group

Primary Treatment: andexanet alfa · Has Placebo Group · Phase 4

andexanet alfa
Drug
Experimental Group · 1 Intervention: andexanet alfa · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours

Who is running the clinical trial?

Alexion PharmaceuticalsLead Sponsor
225 Previous Clinical Trials
36,130 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The study physician must document a decision to enroll the patient into the study.
Time from bleeding symptom onset < 6 hours prior to the baseline imaging scan
You have not been on an oral contraceptive for at least 15 hours prior to randomization.
Patients must be female and male patients of childbearing potential

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.