EUCTR2020-000840-75-HU进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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