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Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Sponsor: Viatris Innovation GmbH
Summary
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25000
Start Date
2021-08-14
Completion Date
2027-07
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Selatogrel
Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
Placebo
Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
Locations (872)
Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
Birmingham VA Health Care System
Birmingham, Alabama, United States
Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
Grandview Medical Center and Affinity Cardiovascular Specialists, LCC
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Dignity Health Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
University of Arizona - Sarver Heart Center
Tucson, Arizona, United States
Amicis Research Center.
Anaheim, California, United States
John Muir Health
Concord, California, United States
Profound Research LLC at San Diego Cardiovascular Associates
La Jolla, California, United States
FOMAT Medical Research
Santa Maria, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
Invivocure
Van Nuys, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
Colorado Heart and Vascular PC
Golden, Colorado, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
FWD Clinical Research
Boca Raton, Florida, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States
Pioneer Clinical Studies (PCS)
Miami, Florida, United States
Baptist Health Care, Inc. d/b/a Baptist Hospital Cardiology
Pensacola, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Endeavor Health
Glenview, Illinois, United States
OSF HealthCare Cardiovascular Institute
Peoria, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Heart Clinic of Hammond
Hammond, Louisiana, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
Sinai Hospital Baltimore, LifeBridge Health
Baltimore, Maryland, United States
Adventist Healthcare White Oak Medical Center
Silver Spring, Maryland, United States
Profound Research LLC at Millenium Cardiology
Farmington Hills, Michigan, United States
MyMichigan Medical Center - Midland
Midland, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
Cardiology Associates Research
Tupelo, Mississippi, United States
University of Missouri Healthcare
Columbia, Missouri, United States
Advanced Heart Care, LLC
Bridgewater, New Jersey, United States
Garden State Advanced Medical Group
Jersey City, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Bassett Medical Center
Cooperstown, New York, United States
St. Joseph's Hospital Cardiology
Liverpool, New York, United States
VA NY Harbor Healthcare System
New York, New York, United States
University of Rochester - PARENT
Rochester, New York, United States
Mecklenburg Heart Specialists
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health
Greensboro, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Wellspan Chambersburg Hospital
Chambersburg, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Donald Guthrie Foundation
Sayre, Pennsylvania, United States
Penn State Health Medical Group - Berks Cardiology
Wyomissing, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.
Rapid City, South Dakota, United States
CHI Institute for Research and Innovation
Chattanooga, Tennessee, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Covenant Medical Group d/b/a Parkway Cardiology Associates
Oak Ridge, Tennessee, United States
Amarillo Heart Clinical Research Institute Inc.
Amarillo, Texas, United States
PharmaTex Research
Amarillo, Texas, United States
Headlands Research Brownsville
Brownsville, Texas, United States
North Texas Research Associates
McKinney, Texas, United States
UVA University Hospital
Charlottesville, Virginia, United States
Inova Heart & Vascular Institute
Falls Church, Virginia, United States
Virginia Heart
Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, LLC
Richmond, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital/ CNARTS
Adelaide, Australia
Grampians Health
Ballarat, Australia
The Prince Charles Hospital
Chermside, Australia
Monash Health
Clayton, Australia
Concord Repatriation General Hospital (CRGH) (Concord Hospital)
Concord, Australia
The Cardiologists Pty. Ltd
Epping, Australia
The Canberra Hospital
Garran, Australia
Gosford Hospital
Gosford, Australia
Tasmanian Health at Royal Hobart Hospital
Hobart, Australia
The Alfred Hospital
Melbourne, Australia
The Royal Melbourne Hospitals
Melbourne, Australia
Hollywood Private Hospital
Nedlands, Australia
Western Health - Sunshine Hospital
St Albans, Australia
John Flynn Private Hospital
Tugun, Australia
Wollongong Hospital - Illawarra Shoalhaven Local Health District
Wollongong, Australia
The Queen Elizabeth Hospital
Woodville South, Australia
LKH Universitätsklinikum Graz
Graz, Austria
Klinikum Klagenfurt am Woerthersse
Klagenfurt, Austria