EUCTR2020-000840-75-IT进行中（未招募）1 期
A Phase IIB, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction, Persistent Inflammation, and Elevated N-terminal Prohormone Brain Natriuretic Peptide - GOLDILOX-TIMI 69
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 792
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 providing signed
- •informed consent, and must adhere to the schedules of activities.
- •2 Participant must be = 40 years of age at the time of signing the informed consent form (ICF).
- •3 Participant must:
- •(a) be 30 to 180 days post-MI (ie, STEMI and NSTEMI) at screening Visit 1.
- •(b) have persistent inflammation, defined as hs CRP = 2 mg/L, as measured centrally at screening Visit 1.
- •(c) have elevated NT proBNP = 125 pg/mL, 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. During the study, enrollment may be capped within 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 634
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 158
排除标准
- •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 providing signed
- •informed consent, and must adhere to the schedules of activities.
- •2 Participant must be = 40 years of age at the time of signing the informed consent form (ICF).
- •3 Participant must:
- •(a) be 30 to 180 days post-MI (ie, STEMI and NSTEMI) at screening Visit 1.
- •(b) have persistent inflammation, defined as hs CRP = 2 mg/L, as measured centrally at screening Visit 1.
- •(c) have elevated NT proBNP = 125 pg/mL, 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. During the study, enrollment may be capped within 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.
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