Health Condition 1: I21- Acute myocardial infarction
Conditions
Interventions
Intervention1: Ziltivekimab: Pharmaceutical form: Solution for injection
Dose and dose frequency : Loading dose:
30 mg (2x15 mg)
Maintenance dose:
15 mg once-monthly
Treatment period: Event driven
Control Intervention1: Placebo: Pharmaceutical form : Solution for injection
Dose and dose frequency : Loading dose:
0 mg (2x0 mg)
Maintenance dose:
0 mg once-monthly
Treatment period: Event driven
Sponsors
Novo Nordisk A S
Eligibility
Inclusion criteria
Inclusion criteria: General 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Age 18 years or above at the time of signing the informed consent. Disease specific 3. Hospitalisation for acute myocardial infarction with evidence of type 1 MI by invasive angiography performed at site with PCI capabilities. a. ST-segment elevation myocardial infarction with all the following: - Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation or during hospitalisation. - ECG-changes (in the absence of left ventricular hypertrophy or left bundle branch block) colon ST-segment elevation at the J point in at least two contiguous leads greater than or equal to 0.25 mV in men less than 40 years, greater than or equal to 0.2 mV in men greater than or equal to 40 years, or greater than or equal to 0.15 mV in women in leads V2-V3; and or greater than or equal to 0.1 mV in all other leads. or b. Non-ST-segment myocardial infarction with all the following: - Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation. - Rise and or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit. 4. Possibility for randomisation as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 48 hours of hospitalisation (time 0) for NSTEMI. 5. Presence of at least one of the following criteria (confirmed based on the participantâ??s medical records and or medical history interview) - Any prior MI. - Prior coronary revascularisation. - Diabetes mellitus treated with glucose-lowering agent(s). - Known CKD (eGFR greater than or equal to 15 and less than 60 mL per min per 1.73 m2). - Prior ischaemic stroke. - Known carotid disease or peripheral artery disease in the lower extremities. - Multivessel coronary artery disease (current or prior) - For STEMI patients only colon anterior MI at index AMI
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of a 3-component MACE endpoint comprising: - CV death - Non-fatal MI - Non-fatal strokeTimepoint: From randomisation (month 0) to end-of study (up to 25 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to occurrence of CV deathTimepoint: From randomisation (month 0) to end-ofstudy (up to 25 months);Time to occurrence of all-cause deathTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Time to first occurrence of a 6-component vascular event endpoint comprising: - CV death - Non-fatal MI - Non-fatal stroke - Ischaemia-driven coronary revascularisation - Non-coronary revascularisation procedure - Any other non-coronary ischaemic event excluding strokeTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Number of CV death, non-fatal MI and non-fatal stroke, ischaemia-driven coronary revascularisation, non-coronary revascularisation procedure, or any other noncoronary ischaemic event excluding strokeTimepoint: From randomisation (month 0) to end-ofstudy (up to 25 months);Number of ischaemia-driven coronary revascularisationTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Time to first occurrence of ischaemia-driven coronary revascularisation or any noncoronary revascularisationTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Number of ischaemia-driven coronary revascularisation or any non-coronary revascularisationTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Number of cardiovascular hospitalisationsTimepoint: From randomisation (month 0) to 1 month or 30 days;Number of hospitalisations with infection as primary cause or death due to infectionTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Change in hs-CRPTimepoint: From randomisation (month 0) to 6 months;Change in haemoglobinTimepoint: From randomisation (month 0) to 12 months;Number of CV death, non-fatal MI or nonfatal strokeTimepoint: From randomisation (month 0) to end-of study (up to 25 months);Time to first occurrence of a composite MACE endpoint consisting of: - All-cause mortality - Non-fatal MI - Non-fatal stro | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Republic of Korea, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India Private Limited,
Outcome results
None listed