RecruitingPHASE3INTERVENTIONAL

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

The ARTEMIS study is looking into a new medicine called ziltivekimab for people who have recently been in hospital due to a heart attack. The main goal is to find out if ziltivekimab can help stop future heart attacks or strokes by protecting the heart. Half of the participants will receive ziltivekimab, and the other half will receive a 'dummy' medicine (placebo) – it's decided by chance. Both medicines are given as a monthly injection just under the skin. Ziltivekimab is new and not currently available from doctors. The study will follow participants for about two years to see how well it works.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

10,000

Start

25 Jun 2024

Estimated completion

14 Dec 2026

Cardiovascular Risk Acute Myocardial Infarction (AMI)

What is this study about?

Heart attacks can be serious, and doctors are always looking for new ways to help people recover and prevent further heart problems. The ARTEMIS study is testing a new medicine named ziltivekimab. It's hoped that this medicine might help reduce the risk of someone who has already had a heart attack from having another one, or even a stroke, by improving their heart health.

This medicine is currently being tested and isn't available for doctors to prescribe yet. Studies like ARTEMIS are really important because they help us understand if new medicines are safe and effective. Participants will help doctors learn whether ziltivekimab makes a real difference compared to a 'dummy' medicine, which looks the same but has no active ingredients.

The study involves people who have recently been admitted to the hospital with a heart attack. By taking part, you would be contributing valuable information that could help many people in the future who are at risk of heart problems.

Key takeaways

ARTEMIS is a new study for people who have had a heart attack.
It tests a new medicine called ziltivekimab to prevent future heart issues.
Participants will get either ziltivekimab or a dummy medicine by monthly injection.
The study lasts about two years and involves regular health checks.
Ziltivekimab is not yet approved and cannot be prescribed by your doctor.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join the ARTEMIS study, you would need to be 18 years old or older. You must have recently been in hospital because of a heart attack where doctors confirmed it was a specific type of heart attack (Type 1 MI) and you had a procedure to open up blocked arteries.

Your heart attack would have needed to show certain changes on an ECG (heart tracing) or a rise in special blood markers called troponins. Also, the study medicine would need to be able to be started soon after your hospital stay.

In addition, you would need to have an extra risk factor for heart problems, such as a previous heart attack, previous heart surgery or a procedure to unblock arteries, diabetes that you take medicine for, or a certain level of kidney disease.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been in hospital due to a heart attack?
Did your heart attack involve a procedure to clear blocked arteries?
Do you have an additional risk factor like diabetes, kidney disease, or a history of heart surgery/previous heart attack?
Can you start a new study medicine soon after your hospital stay?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ARTEMIS study, you would be randomly assigned to receive either ziltivekimab or a placebo (a dummy medicine) – like flipping a coin, each has an equal chance. Neither you nor your study doctor would know which one you are receiving during the study. You would need to learn how to give yourself a monthly injection of the study medicine. This injection is given just under the skin, usually in your tummy, thigh, or upper arm. The study will involve regular check-ups and assessments, which might include blood tests and other tests to monitor your health. The total time you would be involved in the study is about two years, with follow-up appointments during that period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving ziltivekimab, which could reduce your risk of future heart problems. However, it's also possible you could receive the dummy medicine, which has no direct benefit. There might be side effects from taking the study medicine, even if it's the dummy one, and the study team will monitor you closely for these. The injections might cause some discomfort. You are completely free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (970)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Advanced Cardiovascular, LLC
Verified postcode
Alexander City, United States· Active not recruiting
Birmingham VA Medical Center
Verified postcode
Birmingham, United States· Active not recruiting
Grandview Medical Center
Verified postcode
Birmingham, United States· Active not recruiting
Eastern Shore Rsrch Inst, LLC
Verified postcode
Fairhope, United States· Active not recruiting
Heart Center Rsrch_Hunstville
Verified postcode
Huntsville, United States· Active not recruiting
Mobile Heart USA Health Cardiology Clinic
Verified postcode
Mobile, United States· Completed
Mercy Gilbert Medical Center
Verified postcode
Gilbert, United States· Active not recruiting
Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Active not recruiting
Honor Health
Verified postcode
Scottsdale, United States· Completed
Arkansas Cardiology Clinic
Verified postcode
Little Rock, United States· Active not recruiting
Central Arkansas Veteran's Healthcare System
Verified postcode
Little Rock, United States· Not yet recruiting
Valley Clinical Trials
Verified postcode
Covina, United States· Active not recruiting

Common questions

What is ziltivekimab?

Ziltivekimab is a new medicine being tested to see if it can help people who have had a heart attack by preventing future heart problems. It is not currently available from doctors.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but has no active ingredients. It helps doctors see if the new medicine is truly making a difference.

How is the study medicine given?

The study medicine is given as an injection just under the skin once every month. You would learn how to give yourself these injections.

How long does the study last?

The study will last for about two years, during which you will have regular check-ups.

Can I choose which medicine I get?

No, it's decided by chance whether you receive ziltivekimab or the dummy medicine. This helps ensure the study results are fair and accurate.

How to find out more

Novo Nordisk

clinicaltrials@novonordisk.com (+1) 866-867-7178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.