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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Heart Disease (CHD)

In brief

A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.

Key facts

Study ID

NCT04610892

Run by

AstraZeneca

People needed

423

Starts

2020-11-04

Expected to finish

2023-11-08

Last updated by the study team

2025-02-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after signing the full ICF, and must adhere to the schedules of activities.
• Women must be ≥ 40 years of age at the time of signing the ICF. Men must be ≥ 21 years of age at the time of signing the ICF.
• Participant must:
• 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.
• have persistent inflammation, defined as hs CRP ≥ 1 mg/L, as measured centrally at screening Visit 1.
• Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
• For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:
• Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
• Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque.

You may not qualify if…

• 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.
• 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.
• History of or planned coronary artery bypass grafting.
• Documented episode of post-MI pericarditis in the 3 months before enrollment.
• Ongoing New York Heart Association Class IV HF.
• Increased risk of bleeding
• Patients with history or presence of any bleeding disorder.
• 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.
• 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).
• Known severe liver disease.
• History or presence of any of the following:
• Ongoing infection or febrile illness that in the opinion of the investigator may be the cause of elevated hs-CRP on screening.
• Ongoing atrial fibrillation or flutter.
• Cancer within 5 years before randomization, with the exception of non melanoma skin cancer.
• Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
• 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.
• Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
• Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.
• BP values at screening:
• Systolic BP < 90 mmHg or > 180 mmHg.
• Diastolic BP > 100 mmHg.
• Participants who are excluded based on elevated BP may be rescreened following adequate treatment.
• Participants with any of the following contraindications to CTA:
• 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.
• Allergy to iodinated contrast.

Where it is running

• Research Site — Beverly Hills, California, United States
• Research Site — Covina, California, United States
• Research Site — Northridge, California, United States
• Research Site — Northridge, California, United States
• Research Site — Torrance, California, United States
• Research Site — Ponte Vedra, Florida, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Muncie, Indiana, United States
• Research Site — Richmond, Indiana, United States
• Research Site — West Des Moines, Iowa, United States
• Research Site — Midland, Michigan, United States
• Research Site — Columbia, Missouri, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — Canton, Ohio, United States
• Research Site — Rapid City, South Dakota, United States
• Research Site — Winchester, Virginia, United States
• Research Site — Madison, Wisconsin, United States
• Research Site — Adelaide, Australia
• Research Site — Bedford Park, Australia
• Research Site — Clayton, Australia
• Research Site — Murdoch, Australia
• Research Site — Perth, Australia
• Research Site — Ottawa, Ontario, Canada
• Research Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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