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Antidote

andexanet alfa for Stroke

Phase 4
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 12 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Achieved Effective Hemostasis
Secondary study objectives
Percentage Change From Baseline to Nadir in Anti-FXa Activity

Side effects data

From 2023 Phase 4 trial • 530 Patients • NCT03661528
21%
Urinary tract infection
15%
Constipation
15%
Hypokalaemia
11%
Pneumonia
9%
Nausea
9%
Pyrexia
9%
Headache
8%
Delirium
7%
Pneumonia aspiration
7%
Hypertension
5%
Ischaemic stroke
5%
Insomnia
3%
Cerebral haemorrhage
3%
Vomiting
3%
Hydrocephalus
3%
Haemorrhage intracranial
3%
Myocardial infarction
2%
Sepsis
2%
Respiratory failure
1%
Neurological decompensation
1%
Cerebral haematoma
1%
Acute myocardial infarction
1%
Cardiac failure
1%
Upper gastrointestinal haemorrhage
1%
Status epilepticus
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Acute respiratory failure
1%
Pulmonary oedema
1%
Respiratory distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Andexanet Alfa
Usual Care

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: andexanet alfaExperimental Treatment1 Intervention
Patients will receive one of two dosing regimens of andexanet alfa based on which FXa inhibitor they received and the amount and timing of the most recent dose.
Group II: Usual CareExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
andexanet alfa
2019
Completed Phase 4
~530
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
38,097 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
259 Previous Clinical Trials
139,904 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,183 Total Patients Enrolled
~84 spots leftby Oct 2025
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