A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participantswith a Prior Heart Attack
- Conditions
- Myocardial Infarction (MI)MedDRA version: 20.0Level: LLTClassification code 10030272Term: Old myocardial infarctionSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-000840-75-HU
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
1 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.
2 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.
3 Participant must:
(a) 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.
(b) have persistent inflammation, defined as hs-CRP = 1 mg/L, as
measured centrally at screening Visit 1.
4 Participant must have body mass index within the range 18 to 40
kg/m2 inclusive.
5 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:
(a) 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.
(b) Documentation of irreversible surgical sterilization by
hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal
ligation is not considered as irreversible surgical sterilization.
6 Participant must have an evaluable, pre-randomization CTA with
quantifiable, non-calcified plaque, as confirmed by the core laboratory.
Participants will be reassessed for study eligibility before study
intervention is administered on Day 1 (Visit 3). Participants should be
considered for a high-intensity statin based on existing guidelines for
long-term management of patients after an MI. Participants should
ideally be on a stable dose of lipid-lowering therapy throughout the
treatment period of the study; therefore, efforts should be made to
maximize statin intensity before randomization.
The proportion of participants with an NT-proBNP value < 125 pg/mL at
screening who can be randomized to a study intervention may be
capped. If this proportion is capped, a baseline NT-proBNP value of =
125 pg/mL will be required for inclusion in the study. During the study,
randomization to an intervention group may also be capped within other
specific participant subgroups.
In addition to the inclusion criteria specified above, study participants
may elect to take part in the Genomics Initiative; participants who chose
to do this must provide written informed consent before samples are
collected for the optional genetic research that supports the Genomics
Initiative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
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 Visit
1. 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 (eg, Dressler's Syndrome) in the 3 months before enrollment.
5 Ongoing New York Heart Association Class IV (severe) HF.
6 Increased risk of bleeding
(a) Patients with history or presence of any bleeding disorder.
(b) Signs of ongoing bleeding at screening (e.g., identified macroscopic bleeding, low hemoglobin presumed to be cased by bleeding) or high risk for major bleeding in accordance 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 (eg, ascites and/or clinical signs of coagulopathy).
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 (Visit 1).
(b) Ongoing atrial fibrillation or flutter.
(c) Cancer within 5 years before randomization (Day 1; Visit 3), with the exception of non-melanoma skin cancer.
(d) Alcohol or substance abuse within 6 months before randomization (Day 1; Visit 3), 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, including but not limited to:
(a) AST > 2.0 × ULN.
(b) ALT > 2.0 × ULN.
(c) TBL > 1.5 x ULN (unless due to Gilbert's syndrome).
(d) Platelet count < 100000 platelets/µl.
9 BP values at screening Visit 1:
(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. The eligibility assessment is based on measurements taken starting from after 5 minutes of rest; if the result is outside these limits, additional BP measurements can be taken over the following 5 minutes, ie, up to a total of 10 minutes of rest (repeated a maximum of 3 times). If the
result is outside these limits during this period, the participant is considered a screen fail.
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 br
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method