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Milvexian for Acute Coronary Syndrome (LIBREXIA-ACS 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
Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years 6 months
Awards & highlights
LIBREXIA-ACS Trial Summary
This trial tests if a drug (milvexian) can reduce the risk of a major heart event (MACE) compared to a fake drug (placebo).
Who is the study for?
This trial is for adults who recently had a heart-related emergency (acute coronary syndrome) with certain risk factors like being over 65, diabetes, or past heart issues. They must not need chronic blood thinners and should have no major bleeding risks or planned heart surgeries after joining the study.Check my eligibility
What is being tested?
The study tests if Milvexian can better prevent serious heart problems when added to usual treatments compared to a placebo. It focuses on avoiding events like death from heart causes, new heart attacks, and strokes in patients who've just had one such event.See study design
What are the potential side effects?
While specific side effects of Milvexian aren't listed here, similar medications often cause increased bleeding risk. Participants will be monitored for any adverse reactions throughout the trial.
LIBREXIA-ACS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had symptoms of a heart attack and confirmed heart damage within the last week.
LIBREXIA-ACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
Secondary outcome measures
Time to All-cause Mortality (ACM)
Time to Cardiovascular (CV) Death
Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke
+1 moreLIBREXIA-ACS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilvexianExperimental Treatment1 Intervention
Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy [SAPT] or dual antiplatelet therapy [DAPT]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator 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?
Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,368,692 Total Patients Enrolled
4 Trials studying Acute Coronary Syndrome
733,095 Patients Enrolled for Acute Coronary Syndrome
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,114,064 Total Patients Enrolled
9 Trials studying Acute Coronary Syndrome
21,787 Patients Enrolled for Acute Coronary Syndrome
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,944,278 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
3,037 Patients Enrolled for Acute Coronary Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant soon after the study ends.I am 65 or older, have diabetes, or have a history of heart issues.I had symptoms of a heart attack and confirmed heart damage within the last week.I haven't had significant bleeding or a bleeding disorder in the last 3 months.Women who could become pregnant must have a negative pregnancy test before joining the study.I am scheduled for heart bypass surgery or a procedure to open my heart's arteries.I am on long-term blood thinners as advised by my doctor.My heart attack was caused by a lack of oxygen to the heart.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Milvexian
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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What possible adverse effects could be associated with Milvexian usage?
"Our team at Power has assigned a score of 3 to Milvexian's safety profile due to the numerous clinical trials that have demonstrated its efficacy and reliability."
Answered by AI
How widely available is the clinical trial?
"Patients are being enrolled at the Ascension St. Vincent's Health System in Birmingham, Arizona, HH Heart Center and Heart Centre in Huntsville, California, Mobile Hearth Specialists PC in Mobile Colorado alongside a further 862 trial sites."
Answered by AI
Are there any vacancies available for those wishing to participate in this research?
"According to clinicaltrials.gov, this investigation is not currently enrolling patients. The trial was posted on March 8th 2023 and last modified on February 23rd 2023; however, 1457 other trials are actively seeking volunteers at present."
Answered by AI
Who else is applying?
What site did they apply to?
Arkansas Heart Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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