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Milvexian for Stroke (LIBREXIA-STROK Trial)
Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
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 up to global targeted endpoint date (approximately 41 months)
Awards & highlights
LIBREXIA-STROK Trial Summary
This trial tests if a drug can reduce the risk of stroke recurrence.
Who is the study for?
This trial is for adults who've recently had a mild ischemic stroke or high-risk TIA, with specific criteria like NIHSS score <=7 and an ABCD2 Score >=6. They must be able to take low-dose antiplatelet medication and not be at risk of pregnancy. Exclusions include prior serious brain bleeds, strokes from heart problems needing blood thinners, other non-athero-thrombotic causes, bleeding risks, liver disease, or allergies to the study drug.Check my eligibility
What is being tested?
The LIBREXIA-STROKE trial is testing if Milvexian can prevent another stroke better than a placebo (a dummy pill). Participants are chosen randomly to receive either Milvexian or placebo within 48 hours after their initial stroke or TIA symptoms start.See study design
What are the potential side effects?
While the side effects of Milvexian aren't detailed here, common concerns in similar medications may include increased risk of bleeding, potential allergic reactions, and possibly liver issues given the exclusion criteria related to liver health.
LIBREXIA-STROK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to global targeted endpoint date (approximately 41 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to global targeted endpoint date (approximately 41 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Time to First Occurrence of Ischemic Stroke
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke
LIBREXIA-STROK Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilvexianExperimental Treatment1 Intervention
Participants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT [single antiplatelet therapy] or DAPT [dual antiplatelet therapy]) will receive milvexian 25 milligrams (mg), orally, twice daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) will receive placebo orally twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Milvexian
2020
Completed Phase 1
~210
Find a Location
Who is running the clinical trial?
Bristol Myers Squibb Company (BMS)UNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,369,308 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,944,905 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke or TIA with specific conditions met.My stroke or TIA was caused by a reason other than blood clot issues.I had a brain bleed over a year ago and received proper treatment for it.My stroke or TIA was caused by a clot from the heart, and I need blood thinners.I am not pregnant, breastfeeding, nor planning to become pregnant soon after the study ends.I have an active liver disease such as hepatitis or cirrhosis.I am taking or will take blood thinners as recommended, with ASA only in low doses.I have a high risk of bleeding or had significant bleeding in the last 3 months.You are allergic or have a bad reaction to milvexian or any of its ingredients.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Milvexian
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Ischemic Stroke Patient Testimony for trial: Trial Name: NCT05702034 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How much risk is associated with Milvexian usage?
"Our risk assessment yielded Milvexian a score of 3 on the 1-3 scale due to pre-existing data that point towards its efficacy and extensive evidence vouching for its safety."
Answered by AI
Are there a range of healthcare facilities performing this clinical test within the state?
"Glendale Adventist Medical Center in Glendale, California, Southland Neurology in Los Alamitos, Colorado and Kaiser Permanente Northern California in Oakland, Delaware are 3 of the 81 enrolment centres for this study."
Answered by AI
Are there any open positions for individuals to join this trial?
"According to clinicaltrials.gov, the trial is at present not welcoming new enrolments. This investigation was initially made visible on February 9th 2023 and most recently modified on January 19th 2023. While this particular study has reached its capacity for volunteers, there are still 1303 other trials that need participants now."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
New York
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Alberta Hospital
Plaza Neuroscience Clinic
Hackensack University Medical Center
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent pounding headaches possible relief... I have tried other medications but none have resulted in any progress.
PatientReceived 2+ prior treatments
I just had an islemicstroke thank good with no lingering disabalities want to do whatever to not have another one.
PatientReceived 1 prior treatment
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