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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.
- Stroke
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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