Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction

Inclusion Criteria:

1. Participant must provide informed consent before any study specific activities areperformed, must be able and willing to meet all requirements for randomizationwithin 42 days after signing the full ICF, and must adhere to the schedules ofactivities.

2. Women must be ≥ 40 years of age at the time of signing the ICF. Men must be ≥ 21years of age at the time of signing the ICF.

3. Participant must:

4. be 30 to 365 days after presumed type-1 (ie, due to plaque rupture or erosion)MI (either STEMI or NSTEMI) at the time of enrollment.

5. have persistent inflammation, defined as hs CRP ≥ 1 mg/L, as measured centrallyat screening Visit 1.

6. Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.

7. For female participants, the participant must not be pregnant or lactating and mustbe of non-childbearing potential, confirmed at screening Visit 1 by one of thefollowing:

8. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation ofall exogenous hormonal treatments, and with luteinizing hormone and folliclestimulating hormone levels in the postmenopausal range.

9. Documentation of irreversible surgical sterilization by hysterectomy, bilateraloophorectomy, or bilateral salpingectomy. Tubal ligation is not considered asirreversible surgical sterilization.

10. Participant must have an evaluable, pre-randomization CTA with quantifiable, noncalcified plaque.

Exclusion Criteria:

1. History of any clinically important disease or disorder which, in the opinion of theinvestigator, may either put the participant at risk because of participation in thestudy, or influence the results or the participant's ability to participate in thestudy.

2. Percutaneous coronary intervention or diagnostic angiogram planned after screening.Eligible participants who have a diagnostic angiogram performed in the absence ofundergoing a new PCI may continue screening after the diagnostic angiogram has beenperformed 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

7. Patients with history or presence of any bleeding disorder.

8. Signs of ongoing bleeding at screening (eg, identified macroscopic bleeding,low hemoglobin presumed to be caused by bleeding) or high risk for majorbleeding in accordance with the Investigator's assessment.

9. Need for chronic therapeutic anticoagulation therapy anticipated to be requiredthroughout the course of the study (short-term treatment with prophylacticdoses of heparin/low molecular weight heparin are allowed).

10. Known severe liver disease.

11. History or presence of any of the following:

12. Ongoing infection or febrile illness that in the opinion of the investigatormay be the cause of elevated hs-CRP on screening.

13. Ongoing atrial fibrillation or flutter.

14. Cancer within 5 years before randomization, with the exception of non melanomaskin cancer.

15. Alcohol or substance abuse within 6 months before randomization, as judged bythe investigator.

16. Known history of hypersensitivity reactions to other biologics, to human IgGpreparations, or to any component of MEDI6570, or ongoing severe allergy asjudged by the investigator.

17. Patients with active positive results on screening for serum hepatitis Bsurface antigen, hepatitis C antibody, or HIV.

18. Any clinically important abnormalities in clinical chemistry, hematology,coagulation parameters, as judged by the investigator.

19. BP values at screening:

20. Systolic BP < 90 mmHg or > 180 mmHg.

21. Diastolic BP > 100 mmHg.

22. Participants who are excluded based on elevated BP may be rescreened followingadequate treatment.

23. Participants with any of the following contraindications to CTA:

24. eGFR < 50 mL/min/1.73 m2 by the Chronic Kidney Disease EpidemiologyCollaboration equation, or end stage renal disease treated with kidneytransplant or renal replacement therapy.

25. Allergy to iodinated contrast.

26. History of contrast-induced nephropathy.

27. Contraindication to nitroglycerin.

28. Rapid heart rate that is uncontrolled by medical therapy.

29. Inability to hold breath for at least 6 seconds.

30. Receipt of any investigational device or therapy within 6 months or 5 half livesbefore screening (whichever is longer). This criterion does NOT apply for inactive, non replicating COVID-19 vaccinesapproved by Health Authorities or under emergency use authorization.

31. Planned participation in an additional investigational study of an intervention orbiologic before the end of the follow-up period. Participation in observationalstudies or studies without investigational drugs or devices is allowed.

32. Participants who are legally institutionalized.

33. An employee or close relative of an employee of the sponsor, the CRO, or the studysite, regardless of the employee or close relative's role.