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Clinical Trials/EUCTR2020-000840-75-PL
EUCTR2020-000840-75-PLActive, not recruitingPhase 1

A Phase IIB, Randomized, Double blinded, Placebo controlled, Parallelgroup Study to Evaluate the Efficacy and Safety of MEDI6570 inParticipants with a Prior Myocardial Infarction, Persistent Inflammation,and Elevated N terminal Prohormone Brain Natriuretic Peptide - GOLDILOX-TIMI 69

AstraZeneca AB0 sites400 target enrollmentStarted: September 21, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
400
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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
  • •(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

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 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 past 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
  • •(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
  • •(b) Allergy to iodinated contrast.
  • +5 more not shown

Investigators

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