ACTIVE_NOT_RECRUITING

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

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Conditions

Acute Coronary Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-04-07
Study Completion:2026-10-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05754957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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)
  3. * All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
  4. * 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
  1. * MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
  2. * Planned CABG or staged PCI after randomization
  3. * Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines
  4. * Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010
United States
SORRA Research
Birmingham, Alabama, 35203
United States
Ascension St. Vincent's Health System
Birmingham, Alabama, 35205
United States
IMC-Diagnostic and Medical Clinic
Mobile, Alabama, 36604
United States
Cardiology Associates of Mobile Inc
Mobile, Alabama, 36608
United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
United States
Valleywise Health Medical Center
Phoenix, Arizona, 85008
United States
HonorHealth Neurology
Scottsdale, Arizona, 85258
United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
United States
Bakersfield Memorial Hospital
Bakersfield, California, 93306
United States
Mission Cardiovascular Research Institute
Fremont, California, 94538
United States
Radin Cardiovascular Medical Group
Newport Beach, California, 92663
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
Stanford University School of Medicine
Palo Alto, California, 94304
United States
VA Palo Alto Healthcare System
Palo Alto, California, 94304
United States
Huntington Hospital
Pasadena, California, 91105
United States
The Cardiovascular Center
Redding, California, 96001
United States
University Of California San Diego
San Diego, California, 92103
United States
San Diego Cardiac Center
San Diego, California, 92123
United States
VA San Diego Health Care System
San Diego, California, 92161
United States
UCLA
Santa Monica, California, 90401
United States
NorthBay Clinical Research, LLC
Santa Rosa, California, 95405
United States
Ramin Manshadi, MD
Stockton, California, 95204
United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
United States
Nuvance Health Medical Practices Cardiology Danbury
Danbury, Connecticut, 06810
United States
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut, 06905
United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
United States
FWD Clinical Research
Boca Raton, Florida, 33434
United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308
United States
Integrative Research Associates
Fort Lauderdale, Florida, 33312
United States
University of Florida Health Jacksonville
Gainesville, Florida, 32610-0236
United States
Inpatient Research Clinic LLC
Hialeah, Florida, 33014
United States
Shands Jacksonville Medical Center Inc dba UF Health Jacksonville
Jacksonville, Florida, 32209
United States
Cardiology Partners Clinical Research Institute
Loxahatchee Groves, Florida, 33470
United States
Baptist Hospital of Miami
Miami, Florida, 33173
United States
Advanced Research for Health Improvement
Naples, Florida, 34102
United States
Amavita Clinical Research (Dr. Pedro Martinez-Clark)
North Miami Beach, Florida, 33169
United States
South Florida Research Solutions LLC
Pembroke Pines, Florida, 33028
United States
Coastal Cardiology Consultants
Safety Harbor, Florida, 34695
United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239-3513
United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614
United States
Interventional Cardiac Consultants
Trinity, Florida, 34655
United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
United States
Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Atlanta Clinical Research Center
Cartersville, Georgia, 30121
United States
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
United States
Cardiovascular Consultants of South Georgia LLC
Thomasville, Georgia, 31792
United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
United States
Illinois Heart and Vascular Foundation
Chicago, Illinois, 60657
United States
Advocate Heart Institute
Downers Grove, Illinois, 60515
United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
United States
Essential Concepts Research Solutions
Palos Hills, Illinois, 60465
United States
OSF HealthCare Cardiovascular Institute
Peoria, Illinois, 61614
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, 62701
United States
Carle Foundation Hospital
Urbana, Illinois, 61801
United States
Midwest Cardiovascular Research Foundation
Elkhart, Indiana, 46514-2487
United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804
United States
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303
United States
Reid Health
Richmond, Indiana, 47374
United States
Health Midwest Ventures Group, Inc d b a HCA MidAmerica Division, LLC
Overland Park, Kansas, 66209
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Norton Cardiovascular Associates
Louisville, Kentucky, 40205
United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360
United States
Ochsner Clinic And Hospital
New Orleans, Louisiana, 70121
United States
Louisiana Heart Center
Slidell, Louisiana, 70458
United States
Monroe Research LLC
West Monroe, Louisiana, 71291
United States
Eastern Maine Medical Center Northeast Cardiology Associates
Bangor, Maine, 04401
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
United States
Suburban Hospital
Bethesda, Maryland, 20814
United States
Captiol Cardiology Associates
Lanham, Maryland, 20706
United States
Shady Grove Office
Rockville, Maryland, 20850
United States
Tidal Health Peninsula Regional Inc.
Salisbury, Maryland, 21801
United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01830
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
St. Joseph Mercy Oakland
Bloomfield Hills, Michigan, 48302
United States
AAMRC
Flint, Michigan, 48504
United States
Jackson Heart Clinic
Jackson, Michigan, 39216
United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912-1811
United States
St. Luke's Cardiology Associates
Duluth, Minnesota, 55802-2207
United States
HealthEast Medical Research Institute
Saint Paul, Minnesota, 55102
United States
Mercy Medical Research Institute
Chesterfield, Missouri, 63017
United States
The Curators of the University of Missouri on behalf of University of Missouri Health Care
Columbia, Missouri, 65211
United States
North Kansas City Hospital
Kansas City, Missouri, 64116
United States
Spectrum Clinical Research
Kansas City, Missouri, 64118
United States
Cox Health
Springfield, Missouri, 65807
United States
Saint Louis University
St Louis, Missouri, 63110
United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506
United States
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, 68114
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
Ash Research Clinic
Brick, New Jersey, 08724
United States
Englewood Health
Englewood, New Jersey, 07631
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Atlanticare Regional Medical Center
Pomona, New Jersey, 08240
United States
Cardio Metabolic Institute
Somerset, New Jersey, 08873
United States
Buffalo General Medical Center
Buffalo, New York, 14203-1154
United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418
United States
Columbia University Medical Center
New York, New York, 10032
United States
Weil Cornell University
New York, New York, 10065
United States
Weill Cornell Medicine
New York, New York, 10065
United States
Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, 12601
United States
Cardiac Care & Vascular Medicine, PLLC
The Bronx, New York, 10469
United States
Westchester Medical Center
Valhalla, New York, 10532
United States
Clinical Trials of America
Cary, North Carolina, 27518
United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599-5021
United States
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
Atrium Health Wake Forest Baptist
High Point, North Carolina, 27262
United States
Clinical Trials of America
Lenoir, North Carolina, 28645
United States
Novant Health
Matthews, North Carolina, 28105
United States
Rex Hospital
Raleigh, North Carolina, 27607
United States
Sanford Cardiology
Sanford, North Carolina, 27330
United States
Trinity Medical Group
Minot, North Dakota, 58701
United States
Summa Health System
Akron, Ohio, 44304
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Metro Health Hospital
Cleveland, Ohio, 44109
United States
Ohio Health
Columbus, Ohio, 43214
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
The Heart House
Springfield, Ohio, 45504
United States
Ascension Medical Group - St. John Clinic Infectious Disease
Bartlesville, Oklahoma, 74006
United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135
United States
St John Health System Inc
Tulsa, Oklahoma, 74104
United States
Advanced Cardiac Care
Bethlehem, Pennsylvania, 18017
United States
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
United States
Hamot Medical Center
Erie, Pennsylvania, 16507
United States
UPMC Pinnacle Health
Harrisburg, Pennsylvania, 17110
United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
United States
AnMed Health
Anderson, South Carolina, 29621
United States
Prisma Health
Greenville, South Carolina, 29065
United States
St. Francis Physician Services, Inc, DBA Upstate Cardiology Research
Greenville, South Carolina, 29607
United States
Carolina Cardiology Associates
Rock Hill, South Carolina, 29732
United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701
United States
Erlanger Health System
Chattanooga, Tennessee, 37403
United States
Apex Cardiology
Jackson, Tennessee, 38301
United States
Ascension Saint Thomas West Hospital
Nashville, Tennessee, 37205
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
Parkway Cardiology Associates PC
Oak Ridge, Tennessee, 37830
United States
Amarillo Heart Clinical Research Institute
Amarillo, Texas, 79106
United States
PharmaTex Research
Amarillo, Texas, 79109
United States
Med Research, Inc.
El Paso, Texas, 79902
United States
Texas Tech University Health Sciences Center-El Paso
El Paso, Texas, 79905
United States
Baylor Scott and White Research Institute
Fort Worth, Texas, 76104
United States
East Texas Cardiology, PA
Houston, Texas, 77002
United States
Physician Research Network
Houston, Texas, 77027
United States
Vital Heart and Vein
Humble, Texas, 77338
United States
Texas Cardiology Research Center
Kingwood, Texas, 77339
United States
Ascension Texas Cardiovascular
Kyle, Texas, 78640
United States
Cardiovoyage
Sherman, Texas, 75090
United States
Northwest Heart Clinical Research, LLC.
Tomball, Texas, 77375
United States
Virginia Heart
Falls Church, Virginia, 22042
United States
Riverside Regional Medical Center
Newport News, Virginia, 23601
United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
United States
Winchester Medical Center
Winchester, Virginia, 22601
United States
Providence Regional Medical Center Everett
Everett, Washington, 98201
United States
Cardiac Surgery Group
Tacoma, Washington, 98405
United States
MultiCare Health System
Tacoma, Washington, 98405
United States
Mayo Clinic Health System
La Crosse, Wisconsin, 54601-4795
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-07
Study Completion Date2026-10-19

Study Record Updates

Study Start Date2023-04-07
Study Completion Date2026-10-19

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Coronary Syndrome