EUCTR2020-000840-75-NL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
- •(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
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