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Not recruiting

Phase 3

MilvexianA Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05754957

Conditions

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Milvexian

Placebo

Study Details

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).

Conditions

Acute Coronary Syndrome

Study ID

NCT05754957

Start date

Apr 7, 2023

Status verified date

Nov, 2025

Completion date

Oct 19, 2026

Anticipated

Primary completion date

Sep 7, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

16000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Milvexian

Milvexian will be administered orally.

Placebo

Placebo will be administered orally.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Advanced Cardiovascular, LLC

Recruiting

Alexander City, Alabama, United States, 35010

Ascension St. Vincent's Health System

Recruiting

Birmingham, Alabama, United States, 35205

IMC-Diagnostic and Medical Clinic

Recruiting

Mobile, Alabama, United States, 36604

Cardiology Associates of Mobile Inc

Recruiting

Mobile, Alabama, United States, 36608

Mercy Gilbert Medical Center

Recruiting

Gilbert, Arizona, United States, 85297

Valleywise Health Medical Center

Recruiting

Phoenix, Arizona, United States, 85008

HonorHealth Neurology

Recruiting

Scottsdale, Arizona, United States, 85258

Arkansas Heart Hospital

Recruiting

Little Rock, Arkansas, United States, 72211

Bakersfield Memorial Hospital

Recruiting

Bakersfield, California, United States, 93306

Radin Cardiovascular Medical Group

Recruiting

Newport Beach, California, United States, 92663

Valley Clinical Trials, Inc.

Recruiting

Northridge, California, United States, 91325

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

VA Palo Alto Healthcare System

Recruiting

Palo Alto, California, United States, 94304

Huntington Hospital

Recruiting

Pasadena, California, United States, 91105

The Cardiovascular Center

Recruiting

Redding, California, United States, 96001

University Of California San Diego

Recruiting

San Diego, California, United States, 92103

San Diego Cardiac Center

Recruiting

San Diego, California, United States, 92123

VA San Diego Health Care System

Recruiting

San Diego, California, United States, 92161

UCLA

Recruiting

Santa Monica, California, United States, 90401

NorthBay Clinical Research, LLC

Recruiting

Santa Rosa, California, United States, 95405

South Denver Cardiology Associates PC

Recruiting

Littleton, Colorado, United States, 80120

George Washington University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20037

FWD Clinical Research

Recruiting

Boca Raton, Florida, United States, 33434

Clearwater Cardiovascular Consultants

Recruiting

Clearwater, Florida, United States, 33756

Holy Cross Hospital Inc.

Recruiting

Fort Lauderdale, Florida, United States, 33308

Inpatient Research Clinic LLC

Recruiting

Hialeah, Florida, United States, 33014

Shands Jacksonville Medical Center Inc dba UF Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Cardiology Partners Clinical Research Institute

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Baptist Hospital of Miami

Recruiting

Miami, Florida, United States, 33173

Advanced Research for Health Improvement

Recruiting

Naples, Florida, United States, 34102

Amavita Clinical Research (Dr. Pedro Martinez-Clark)

Recruiting

North Miami Beach, Florida, United States, 33169

South Florida Research Solutions LLC

Recruiting

Pembroke Pines, Florida, United States, 33028

Coastal Cardiology Consultants

Recruiting

Safety Harbor, Florida, United States, 34695

Cardiovascular Center of Sarasota

Recruiting

Sarasota, Florida, United States, 34239-3513

Tampa Cardiovascular Interventions and Research

Recruiting

Tampa, Florida, United States, 33614

Interventional Cardiac Consultants

Recruiting

Trinity, Florida, United States, 34655

Cardiology Partners Clinical Research Institute

Recruiting

Wellington, Florida, United States, 33449

Northeast Georgia Heart Center

Recruiting

Gainesville, Georgia, United States, 30501

Cardiovascular Consultants of South Georgia LLC

Recruiting

Thomasville, Georgia, United States, 31792

Kootenai Medical Center

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Insight Hospital and Medical Center Chicago

Recruiting

Chicago, Illinois, United States, 60616

Illinois Heart and Vascular Foundation

Recruiting

Chicago, Illinois, United States, 60657

Advocate Heart Institute

Recruiting

Downers Grove, Illinois, United States, 60515

OSF HealthCare Cardiovascular Institute

Recruiting

Peoria, Illinois, United States, 61614

Methodist Medical Center of Illinois

Recruiting

Peoria, Illinois, United States, 61636

Prairie Cardiovascular Consultants, Ltd.

Recruiting

Springfield, Illinois, United States, 62701

Midwest Cardiovascular Research Foundation

Recruiting

Elkhart, Indiana, United States, 46514-2487

IU Health Ball Memorial Hospital

Recruiting

Muncie, Indiana, United States, 47303

Reid Health

Recruiting

Richmond, Indiana, United States, 47374

Health Midwest Ventures Group, Inc d b a HCA MidAmerica Division, LLC

Recruiting

Overland Park, Kansas, United States, 66209

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Norton Cardiovascular Associates

Recruiting

Louisville, Kentucky, United States, 40205

Ochsner Clinic And Hospital

Recruiting

New Orleans, Louisiana, United States, 70121

Monroe Research LLC

Recruiting

West Monroe, Louisiana, United States, 71291

Eastern Maine Medical Center Northeast Cardiology Associates

Recruiting

Bangor, Maine, United States, 04401

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21231

Suburban Hospital

Recruiting

Bethesda, Maryland, United States, 20814

Captiol Cardiology Associates

Recruiting

Lanham, Maryland, United States, 20706

Shady Grove Office

Recruiting

Rockville, Maryland, United States, 20850

Tidal Health Peninsula Regional Inc.

Recruiting

Salisbury, Maryland, United States, 21801

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

St. Joseph Mercy Oakland

Recruiting

Bloomfield Hills, Michigan, United States, 48302

Jackson Heart Clinic

Recruiting

Jackson, Michigan, United States, 39216

Sparrow Clinical Research Institute

Recruiting

Lansing, Michigan, United States, 48912-1811

St. Luke's Cardiology Associates

Recruiting

Duluth, Minnesota, United States, 55802-2207

Mercy Medical Research Institute

Recruiting

Chesterfield, Missouri, United States, 63017

The Curators of the University of Missouri on behalf of University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65211

Spectrum Clinical Research

Recruiting

Kansas City, Missouri, United States, 64118

Cox Health

Recruiting

Springfield, Missouri, United States, 65807

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

Bryan LGH Heart Institute

Recruiting

Lincoln, Nebraska, United States, 68506

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Ash Research Clinic

Recruiting

Brick, New Jersey, United States, 08724

Englewood Health

Recruiting

Englewood, New Jersey, United States, 07631

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Atlanticare Regional Medical Center

Recruiting

Pomona, New Jersey, United States, 08240

Cardio Metabolic Institute

Recruiting

Somerset, New Jersey, United States, 08873

Buffalo General Medical Center

Recruiting

Buffalo, New York, United States, 14203-1154

Jamaica Hospital Medical Center

Recruiting

Jamaica, New York, United States, 11418

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Weil Cornell University

Recruiting

New York, New York, United States, 10065

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10532

UNC School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599-5021

The Moses H. Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

Novant Health

Recruiting

Matthews, North Carolina, United States, 28105

Rex Hospital

Recruiting

Raleigh, North Carolina, United States, 27607

Sanford Cardiology

Recruiting

Sanford, North Carolina, United States, 27330

Trinity Medical Group

Recruiting

Minot, North Dakota, United States, 58701

Summa Health System

Recruiting

Akron, Ohio, United States, 44304

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Ohio Health

Recruiting

Columbus, Ohio, United States, 43214

Kettering Medical Center

Recruiting

Kettering, Ohio, United States, 45429

South Oklahoma Heart Research

Recruiting

Oklahoma City, Oklahoma, United States, 73135

St John Health System Inc

Recruiting

Tulsa, Oklahoma, United States, 74104

Advanced Cardiac Care

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Chambersburg Hospital

Recruiting

Chambersburg, Pennsylvania, United States, 17201

Hamot Medical Center

Recruiting

Erie, Pennsylvania, United States, 16507

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Lankenau Institute for Medical Research

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29065

St. Francis Physician Services, Inc, DBA Upstate Cardiology Research

Recruiting

Greenville, South Carolina, United States, 29607

Monument Health Clinical Research

Recruiting

Rapid City, South Dakota, United States, 57701

Erlanger Health System

Recruiting

Chattanooga, Tennessee, United States, 37403

Ascension Saint Thomas West Hospital

Recruiting

Nashville, Tennessee, United States, 37205

Amarillo Heart Clinical Research Institute

Recruiting

Amarillo, Texas, United States, 79106

PharmaTex Research

Recruiting

Amarillo, Texas, United States, 79109

Med Research, Inc.

Recruiting

El Paso, Texas, United States, 79902

Texas Tech University Health Sciences Center-El Paso

Recruiting

El Paso, Texas, United States, 79905

East Texas Cardiology, PA

Recruiting

Houston, Texas, United States, 77002

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

Ascension Texas Cardiovascular

Recruiting

Kyle, Texas, United States, 78640

Cardiovoyage

Recruiting

Sherman, Texas, United States, 75090

Northwest Heart Clinical Research, LLC.

Recruiting

Tomball, Texas, United States, 77375

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

Riverside Regional Medical Center

Recruiting

Newport News, Virginia, United States, 23601

Sentara Cardiovascular Research Institute

Recruiting

Norfolk, Virginia, United States, 23507

Winchester Medical Center

Recruiting

Winchester, Virginia, United States, 22601

Providence Regional Medical Center Everett

Recruiting

Everett, Washington, United States, 98201

Cardiac Surgery Group

Recruiting

Tacoma, Washington, United States, 98405

Mayo Clinic Health System

Recruiting

La Crosse, Wisconsin, United States, 54601-4795

Foothills Hospital

Recruiting

Calgary, Alberta, Canada, T2N4N2

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Surrey Memorial Hospital

Recruiting

Surrey, British Columbia, Canada, V2V 0C6

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Saint Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3J 3R4

Dr. Saul Vizel Cardiac Research Office

Recruiting

Cambridge, Ontario, Canada, N1R 7R1

Hamilton Health Sciences Corporation

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2R2

Halton Healthcare Services Corporation

Recruiting

Oakville, Ontario, Canada, L6M 0L8

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Niagara Health System

Recruiting

St. Catharines, Ontario, Canada, L2S 0A9

Toronto Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Office of Dr. Anthony Glanz

Recruiting

Windsor, Ontario, Canada, N8X 5A6

Clinique de Cardiologie de Levis

Recruiting

Lévis, Quebec, Canada, G6V 4Z5

Centre de Recherche du CHUM

Recruiting

Montreal, Quebec, Canada, H2L 4M1

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Montreal Heart Institute

Recruiting

Québec, Quebec, Canada, 00

Centre de Recherche Clinique de Quebec

Recruiting

Québec, Quebec, Canada, G1J 1Z6

Institut Universitaire De Cardiologie Et De Pneumologie De Québec

Recruiting

Québec, Quebec, Canada, G1V 4G5

CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur d/b/a CISSS de Lanaudiere

Recruiting

Terrebonne, Quebec, Canada, J6V 2H2

CIUSSS de la Mauricie-et-du-Centre-du-Quebec

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2025-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.