16000 Participants Needed

Milvexian for Acute Coronary Syndrome

(LIBREXIA-ACS Trial)

Recruiting at 1113 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new medication called milvexian to see if it can better prevent serious heart problems like heart attacks and strokes in patients who are at high risk. The medication works by preventing blood clots, which helps keep blood flowing smoothly.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic anticoagulation therapy, you may not be eligible to participate.

Is Milvexian generally safe for humans?

The available research does not provide specific safety data for Milvexian, but it highlights that adverse events can occur in clinical trials, even with placebo treatments. Common side effects in similar studies include headaches and drowsiness, but no life-threatening events were reported.12345

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion 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.
See 1 more

Exclusion Criteria

I haven't had significant bleeding or a bleeding disorder in the last 3 months.
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.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive either milvexian or placebo, in addition to standard-of-care, to evaluate the reduction in risk of major adverse cardiovascular events

Up to 3 years 6 months
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Milvexian
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilvexianExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).
Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.
Adverse events in phase-I studies: a report in 1015 healthy volunteers.Sibille, M., Deigat, N., Janin, A., et al.[2019]
In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).
Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.
Adverse events in phase one studies: a study in 430 healthy volunteers.Sibille, M., Deigat, N., Olagnier, V., et al.[2019]
A multicenter study involving 300 patients demonstrated that an active pharmacovigilance model, using structured phone interviews, effectively identified a higher incidence of severe hemorrhage in patients using acetylsalicylic acid (ASA) compared to those using other non-ASA NSAIDs, highlighting a specific risk associated with this subclass.
The study suggests that this active pharmacovigilance approach can uncover hidden adverse drug reactions (ADRs) that may not be evident in traditional methods, making it a valuable tool for monitoring the safety of widely used medications.
A new model of pharmacovigilance? A pilot study.Zancan, A., Locatelli, C., Ramella, F., et al.[2013]

Citations

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]
Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]
A new model of pharmacovigilance? A pilot study. [2013]
The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]
EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security