CTRI/2024/06/068283尚未招募3 期
Effects of ziltivekimab versus placebo on cardiovascular outcomes inpatients with acute myocardial infarction - ARTEMIS
ovo Nordisk A S0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •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
排除标准
- •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
研究者
相似试验
招募中
3 期
Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammatiosystemische ontstekingenAtherosclerotic cardiovascular disease and chronic kidney disease1008220610038430NL-OMON54148ovo Nordisk120
招募中
3 期
Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammatioASCVD, CKD and systemic inflammationJPRN-jRCT2021210033Miyazaki Daisuke400
招募中
3 期
A research study to look at how ziltivekimab works compared to placebo in people with heart failure and inflammation.heart failure with mildly reduced or preserved ejection fraction and systemic inflammationJPRN-jRCT2031230085Hirata Takashi120
已完成
3 期
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and InflammationChronic Kidney DiseaseNCT05021835Novo Nordisk A/S6,385
招募中
3 期
ATHENA: A research study looking into how ziltivekimab works compared to placebo in peoplewith heart failure and inflammatioCTRI/2024/03/064154ovo Nordisk A S