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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 12 hours
Awards & highlights

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
  • Stroke

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemostatic function
Secondary outcome measures
To evaluate the effect of andexanet versus usual care on anti-fXa activity.

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
~7710

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
38,847 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
40,722 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,993 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior investigations have been conducted on andexanet alfa's efficacy?

"Currently, there is one clinical trial investigating andexanet alfa in which 0 are Phase 3. Although the primary research site for this medication is located in Toulon, Ontario, 394 other sites have been identified to actively study it."

Answered by AI

How many venues are using this experiment to investigate the effects of a new medication?

"This clinical trial has 72 recruiting sites, including Royal Columbian Hospital in New Westminster, University of Calgary, Foothills Medical Center in New york and London Health Sciences Centre in Oklahoma City. There are many more locations actively participating as well."

Answered by AI

Are there any opportunities for individuals to become involved in this experiment?

"Affirmative. Clinicaltrials.gov states that the trial, which was first advertised on June 6th 2019, is enrolling candidates at this time in point. Approximately 1200 participants are needed from 72 different research sites."

Answered by AI

Is participation in this medical trial open to those under seventy-five years of age?

"According to the established parameters, potential participants must be at least 18 years old and no older than 89."

Answered by AI

Is this an unprecedented scientific investigation?

"Currently, there is only one active trial of andexanet alfa being conducted worldwide in 24 countries across 48 cities. This study was first initiated by Alexion Pharmaceuticals in 2019 and involved over 1200 participants. It has since completed Phase 4 approval and 18689 more trials have been launched since then."

Answered by AI

Would I be eligible to take part in this investigation?

"This medical trial is searching for 1200 individuals who have experienced brain hemorrhage, ranging from ages 18 to 89. Eligibility also requires that participants comply with certain criteria including deferred consent procedures (if permitted by regional laws), time of symptom onset within 6 hours prior to the baseline imaging scan, written informed consent obtained as soon as possible after study entry, and avoiding pregnancy for 30 days following the last dose of medication."

Answered by AI

How many people are being inducted into this research program?

"Affirmative. Information published on clinicaltrials.gov shows that this research programme is actively recruiting participants, having first been postedon June 6th 2019 and last updated October 31st 2022. 1,200 individuals are needed to take part in the trial across 72 different sites."

Answered by AI

What are the potential adverse effects associated with andexanet alfa?

"Andexanet alfa has already been approved, so it is classified as a level 3 due to the amount of evidence supporting its safety."

Answered by AI
~92 spots leftby Mar 2025