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ACTIVE NOT RECRUITING

NCT06118281

PHASE3

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Official title: ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10000

Start Date

2024-06-25

Completion Date

2027-01-29

Last Updated

2026-09-09

Healthy Volunteers

Conditions

Cardiovascular Risk Acute Myocardial Infarction (AMI)

Interventions

DRUG

Ziltivekimab

Ziltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.

DRUG

Placebo

Placebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.

Key inclusion: * Age 18 years or above at the time of signing the informed consent. * Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities. * ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation, at the investigator's discretion. b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal 0.25 (millivolt) mV in men less than 40 years, greater than or equal 0.2 mV in men greater than or equal 40 years, or greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal 0.1 mV in all other leads. OR * Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation, at the investigator's discretion. b) Rise and/or fall in car-diac troponin I or T with at least one value above the 99th percentile upper reference limit. * Possibility for both randomisation and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 72 hours of hospitalisation (time 0) for NSTEMI. * Presence of at least one of the following criteria confirmed based on the participant's medical records and/or medical history interview: a) Any prior MI. b) Prior coronary revascularisation. c) Diabetes mellitus treated with ongoing glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2). e) Prior ischaemic stroke. f) Known carotid disease or peripheral artery disease in the lower extremities. g) Multivessel coronary artery disease (current/prior). h) For STEMI patients only: anterior MI at index acute myocardial infarction (AMI) Key exclusion: * Use of fibrinolytic therapy for treatment of the current AMI. * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV. * Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV. b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg)). * Severe kidney impairment defined as any of the following: a) eGFR less than 15 mililitre per minute per 1.73 m\^2. b) Chronic haemodialysis or peritoneal dialysis. * Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN). * Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation). b) Previously known or current ascites (clinical eval-uation). c) Jaundice (clinical evaluation). d) Previous oesophageal/gastric variceal bleeding. c) Known hepatic cirrhosis. * Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery (CABG)), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged)percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed. * Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. * Known (acute or chronic) hepatitis B or hepatitis C. * History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation. b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2).

Locations (836)

Advanced Cardiovascular, LLC

Alexander City, Alabama, United States

Birmingham VA Medical Center

Birmingham, Alabama, United States

Grandview Medical Center

Birmingham, Alabama, United States

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, United States

Heart Center Rsrch_Hunstville

Huntsville, Alabama, United States

Mobile Heart USA Health Cardiology Clinic

Mobile, Alabama, United States

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

Honor Health

Scottsdale, Arizona, United States

Arkansas Cardiology Clinic

Little Rock, Arkansas, United States

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, United States

Valley Clinical Trials

Covina, California, United States

UCSD Medical Center

La Jolla, California, United States

Loma Linda University Faculty Medical Clinics

Loma Linda, California, United States

VAGrtrLosAngelesHlthcareSystem

Los Angeles, California, United States

University of Californ LA-UCLA

Los Angeles, California, United States

University Of California Irvine

Orange, California, United States

Kaiser Permanente Viewridge Medical Offices

San Diego, California, United States

San Diego Cardiac Center

San Diego, California, United States

San Francisco V.A. Medical Center

San Francisco, California, United States

LA BioMed Harbor UCLA Med Cenr

Torrance, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

Interventional Cardiology Medical Group

West Hills, California, United States

University of CO - Division of Cardiology

Aurora, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Colorado Heart and Vascular PC

Golden, Colorado, United States

S Denver Cardiology Associates

Littleton, Colorado, United States

Advanced Heart & Vein Center

Thornton, Colorado, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Danbury Hospital - Cardiology Department

Danbury, Connecticut, United States

Yale Ctr for Clin Invest

New Haven, Connecticut, United States

Cardiology Associates of Fairfield County

Stamford, Connecticut, United States

Christiana Care Health Services, Inc.

Newark, Delaware, United States

MedStar Hlth Res Institute

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

Holy Cross Hospital

Fort Lauderdale, Florida, United States

University of Florida

Gainesville, Florida, United States

Memorial Healthcare

Hollywood, Florida, United States

UF Hlth Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Baptist Heart Specialists

Jacksonville, Florida, United States

Baptist Hospital Cardiology

Pensacola, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

Winter Haven Hospital

Winter Haven, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Atlanta VAMC

Decatur, Georgia, United States

Northeast Georgia Medical Ctr

Gainesville, Georgia, United States

Cardio. Consult. of S. GA

Thomasville, Georgia, United States

St. Luke's Idaho Cardiology Associates

Meridian, Idaho, United States

Endeavor Health Glenbook Hosp

Evanston, Illinois, United States

OSF HealthCare_Cardiovasc Inst

Rockford, Illinois, United States

Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, United States

Midwest Cardiovascu Rsrch Foundation

Elkhart, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Reid Physician Associates

Richmond, Indiana, United States

MercyOne NE Iowa Fam Med & Res

Waterloo, Iowa, United States

University Of Kansas Hospital

Kansas City, Kansas, United States

Midwest Heart and Vascular Specialists

Overland Park, Kansas, United States

Saint Elizabeth Medical Center

Edgewood, Kentucky, United States

University Of Louisville

Louisville, Kentucky, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Overton Brooks V.A. Medical Center

Shreveport, Louisiana, United States

Northern Light Eastern Maine Medical Center

Bangor, Maine, United States

Maine Medical Center Bramhall

Portland, Maine, United States

MedStar Hlth Res Institute

Clinton, Maryland, United States

Adventist HealthCare Shady Grove Medical Center

Rockville, Maryland, United States

Jadestone Clinical Research, LLC

Silver Spring, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

McLaren Bay Region

Bay City, Michigan, United States

Wayne State University/University Health Center

Detroit, Michigan, United States

WMU Homer Stryker MD School of Medicine

Kalamazoo, Michigan, United States

McLaren Greater Lansing

Lansing, Michigan, United States

MidMic Medical Cntr - Midland

Midland, Michigan, United States

McLaren Macomb Health Care

Mount Clemens, Michigan, United States

McLaren Northern MI Hosp

Petoskey, Michigan, United States

Trinity Health Oakland Hospital

Pontiac, Michigan, United States

Corewell Health

Royal Oak, Michigan, United States

Ascension St. Mary's Research Institute - Michigan

Southfield, Michigan, United States

Trinity Health Michigan Heart

Ypsilanti, Michigan, United States

Essentia Health

Duluth, Minnesota, United States

Fairview Health Services

Maplewood, Minnesota, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

VA Medical Center_Minneapolis

Minneapolis, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Univ of Mississippi Med Center

Jackson, Mississippi, United States

Cardiolg Assoc Rsch LLC_Tupelo

Tupelo, Mississippi, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Missouri Cardiovascular Specialist

Columbia, Missouri, United States

North Kansas City Hospital

North Kansas City, Missouri, United States

Mercy Research

Springfield, Missouri, United States

Washington University School of Medicine_St. Louis

St Louis, Missouri, United States

Methodist Physicians Clinic

Omaha, Nebraska, United States

UMC of Southern Nevada

Las Vegas, Nevada, United States

Dartmouth-Hitchcock Med Ctr

Lebanon, New Hampshire, United States

Advanced Heart Care LLC

Bridgewater, New Jersey, United States

Virtua Health

Camden, New Jersey, United States

Hackensack Meridian Health - Cardiovascular

Hackensack, New Jersey, United States

The Heart House Haddon Heights

Haddon Heights, New Jersey, United States

And 736 more locations on ClinicalTrials.gov

Clinical Research Directory

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (836)