Efficacy and Safety of MEDI6570 in Patients with a History of Myocardial Infarction - GOLDILOX

Exclusion Criteria

• 1 History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
• 2 Percutaneous coronary intervention or diagnostic angiogram planned after screening. Eligible participants who have a diagnostic angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.
• 3 History of or planned coronary artery bypass grafting.
• 4 Documented episode of post-MI pericarditis in the 3 months before enrollment.
• 5 Ongoing New York Heart Association Class IV HF.
• 6 Increased risk of bleeding
• (a) Patients with history or presence of any bleeding disorder.
• (b) Signs of ongoing bleeding at screening (eg, identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator’s assessment.
• (c) Need for chronic therapeutic anticoagulation therapy anticipated to be required throughout the course of the study (short-term treatment with prophylactic doses of heparin/low molecular weight heparin are allowed).
• (d) Known severe liver disease.
• 7 History or presence of any of the following:
• (a) Ongoing infection or febrile illness that in the opinion of the investigator may be the cause of elevated hs-CRP on screening.
• (b) Ongoing atrial fibrillation or flutter.
• (c) Cancer within 5 years before randomization, with the exception of non melanoma skin cancer.
• (d) Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
• (e) Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of MEDI6570, or ongoing severe allergy as judged by the investigator.
• (f) Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
• 8 Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.
• 9 BP values at screening:
• (a) Systolic BP < 90 mmHg or > 180 mmHg.
• (b) Diastolic BP > 100 mmHg.
• (c) Participants who are excluded based on elevated BP may be rescreened following adequate treatment.
• 10 Participants with any of the following contraindications to CTA:
• (a) eGFR < 50 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy.
• (b) Allergy to iodinated contrast.
• (c) History of contrast-induced nephropathy.
• (d) Contraindication to nitroglycerin.
• (e) Rapid heart rate that is uncontrolled by medical therapy.
• (f) Inability to hold breath for at least 6 seconds.
• 11 Receipt of any investigational device or therapy within 6 months or 5 half lives before screening (whichever is longer).
• This criterion does NOT apply for inactive, non replicating COVID-19 vaccines approved by Health Authorities or under emergency use authorization.
• 12 Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed.
• 13 Participants who are legally institutionalized.
• 14 An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative’s role.