ARTEMIS - A research study to look at how ziltivekimab works compared to placeboin people with a heart attack
- Conditions
- Health Condition 1: I21- Acute myocardial infarction
- Registration Number
- CTRI/2024/06/068283
- Lead Sponsor
- ovo Nordisk A S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 participant’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
1. Known or suspected hypersensitivity to study intervention or related products.
2. Previous participation in this study. Participation is defined as randomisation.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
potential and not using an adequate and highly effective contraceptive method (adequate
contraceptive measures as required by local regulation or practice), as defined in Appendix 4,
Section 10.4.2.
4. Participation (i.e., signed informed consent) in any other interventional clinical study of an
approved or non-approved investigational medicinal product within the past 30 days.
5. Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or
compliance with the protocol.
Laboratory values
6. Absolute neutrophil count less than 2 x 109 per L.
7. Platelet count less than 120 x 109 per L.
8. ALT greater than 8 x ULN.
Medical conditions – cardiac and risk factors
9. Use of fibrinolytic therapy for treatment of the current AMI.
10. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV.
11. 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 mmHg).
12. Severe kidney impairment defined as any of the following
a Previous or current eGFR less than 15 mL per min per 1.73 m2.
b Chronic haemodialysis or peritoneal dialysis.
13. 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 evaluation).
c Jaundice (clinical evaluation).
d Previous oesophageal or gastric variceal bleeding.
e Known hepatic cirrhosis.
14. 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.
Medical conditions – infections
15. History of recurrent serious infections (infections leading to hospitalisation or use of i. v. antibiotics) within the past 12 months, at the discretion of the investigator.
16. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
17. Known (acute or chronic) hepatitis B or hepatitis C.
18. History or evidence of untreated latent tuberculosis (TB) such as (but not limited to)
a History or evidence of a positive TB test or chest X-ray compatible with latent TB semi colon and TB treatment initiated less than 28 days prior to randomisation.
b Participants with TB risk factors (see details in Section 8.2.6) unwilling to undergo TB
treatment if confirmed positive for latent TB based on central laboratory test at baseline
(visit 2).
19. Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral
regimen, at the discretion of the inves
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method