A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (LIBREXIA-ACS)

• ClinicalTrials.gov Identifier: NCT05754957
• Recruitment Status: Recruiting
• First Posted: March 6, 2023
• Last Update Posted: April 24, 2024
• Sponsor: Janssen Research & Development, LLC
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: February 23, 2023
• First Posted Date: March 6, 2023
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: April 7, 2023
• Estimated Primary Completion Date: September 7, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2023)

Time to First Occurrence of Major Adverse Cardiovascular Event (MACE) [ Time Frame: Up to 3 years 6 months ]

Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 23, 2023)

• Time to the First Occurrence of Major Adverse Vascular Event (MAVE) [ Time Frame: Up to 3 years 6 months ]
  Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).
• Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke [ Time Frame: Up to 3 years 6 months ]
  Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.
• Time to Cardiovascular (CV) Death [ Time Frame: Up to 3 years 6 months ]
  Time to CV death will be reported.
• Time to All-cause Mortality (ACM) [ Time Frame: Up to 3 years 6 months ]
  Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
• Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
• Brief Summary: The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Coronary Syndrome

Intervention

• Drug: Milvexian
  Milvexian will be administered orally.
  Other Names:

  • JNJ-70033093
  • BMS-986177
• Other: Placebo
  Placebo will be administered orally.

Study Arms

• Experimental: Milvexian
  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.
  Intervention: Drug: Milvexian
• Placebo Comparator: Placebo
  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.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 23, 2023): 16000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 19, 2026
• Estimated Primary Completion Date: September 7, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
• Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention [PCI] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)
• All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
• A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention

Exclusion Criteria:

• MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
• Planned CABG or staged PCI after randomization
• Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines
• Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
• Removed Location Countries: Estonia, Greece, Mexico, Philippines, Singapore, Vietnam

Administrative Information

• NCT Number: NCT05754957
• Other Study ID Numbers: CR109271; 70033093ACS3003 ( Other Identifier: Janssen Research & Development, LLC ); 2022-501418-69-00 ( Registry Identifier: EUCT number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Current Responsible Party: Janssen Research & Development, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Janssen Research & Development, LLC
• Original Study Sponsor: Same as current
• Collaborators: Bristol-Myers Squibb

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

• PRS Account: Janssen Research & Development, LLC
• Verification Date: April 2024