4979 ARTEMIS - ziltivekimab vs placebo on CVOT in patients with acute MI
Research type
Research Study
Full title
ARTEMIS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction.
IRAS ID
1009307
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2023-506876-28
Clinicaltrials.gov Identifier
Research summary
We are doing this study to see if a new medicine, ziltivekimab, can be used to treat people who have been admitted to hospital because of a heart attack. People that experience a heart attack are at risk of suffering from a new heart attack or stroke (blocked blood supply to the brain) in the future. This is due to a continuous build-up of fat in the blood vessels, so-called plaque, which is driven by a process known as ‘inflammation’. Inflammation is a crucial process for wound healing and to fight off bacteria and viruses, but sometimes inflammation can be bad for us. Untreated inflammation leads to build-up of fat in the blood vessels and can restrict blood flow to the heart and brain. Completed studies showed that ziltivekimab can lower inflammation, which may reduce development of heart disease and stroke.
This study is planned to be conducted at hospitals in 24 countries in about 10,000 men and women. Participants will be randomly given either ziltivekimab or placebo (a dummy drug) by subcutaneous (under the skin) injection once a month, in addition to their usual treatment for the condition.
The study is event driven, meaning that the end of the study will depend on the accumulated number of major adverse cardiovascular events (MACE). The total time each participant is expected to be in this study is about 25 months, including 2 visits during their initial stay in hospital, a further 22 months during which the participant will visit the hospital on 8 occasions and have 3 phone calls with the study team, followed by a final visit 3 months after the last dose of study medicine. During the study participants will have health checks, including physical examinations and blood tests, and will complete a questionnaire at 3 visits.
This study is being funded by Novo Nordisk.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0060
Date of REC Opinion
27 Mar 2024
REC opinion
Further Information Unfavourable Opinion