Principal Investigator:
Study sponsor: Novo Nordisk
Location: Regions Hospital
Phase of Study: III
Purpose of study: Coronary atherosclerotic disease is the most common cause of death world-wide, with a particularly poor prognosis in patients with who have experienced a heart attack. Despite aggressive standard of care treatment with antiplatelet- and anti-dyslipidemia drugs, these patients continue to have a high residual risk for future cardiac events. Inflammation plays a crucial role in the initiation, progression and destabilization of plaques and is associated with a higher cardiovascular risk. Ziltivekimab is a human monoclonal antibody that appears to reduce inflammation. The aim of the current study is to demonstrate the efficacy and safety of ziltivekimab in reducing the risk of major adverse CV events when initiated as early as possible in adult patients who were hospitalized for heart attack.
Inclusion Criteria:
1. Age 18 years or above at the time of signing the informed consent.
2. Hospitalization for acute myocardial infarction with evidence of type 1 MI by invasive angiography performed at site with PCI capabilities.
3. Possibility for both randomization and administration of the loading dose of study intervention as early as possible after invasive
procedure, and latest within 36 hours of hospitalization (time 0) for STEMI, and latest within 72 hours of hospitalization (time 0) for
NSTEMI.
4. Presence of at least one of the following criteria confirmed based on the participant’s
medical records and/or medical history interview:
o Any prior MI
o Prior coronary revascularization
o Diabetes mellitus treated with ongoing glucose-lowering agent(s).
o Known CKD
o Prior ischemic stroke
o Known carotid disease or peripheral artery disease in the lower extremities
o Multivessel coronary artery disease (current/prior).
Exclusion Criteria:
1. Use of fibrinolytic therapy for treatment of the current AMI.
2. Chronic heart failure.
3. Ongoing hemodynamic instability.
4. Severe kidney impairment.
5. Severe hepatic disease.
6. Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure within the past 60 days or any major surgical procedure planned.
7. Clinical evidence of, or suspicion of, active infection.
8. Known (acute or chronic) hepatitis B or hepatitis C.
9. History or evidence of untreated latent tuberculosis (TB).
Study Contact:
Kirsten Dalrymple
(651) 254-5316
Kirsten.A.Dalrymple@healthpartners.com
