NL-OMON52059已完成2 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
Astra Zeneca0 个研究点目标入组 85 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1 Participant must provide informed consent before any study specific
- •activities are performed (Appendix A 3), 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 Participant must be >= 40 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
- •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 (Appendix D 2).
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 [PCI] planned after screening Visit 1.
- •Eligible participants who have a PCI planned after screening Visit 1 may be
- •rescreened after the PCI has been performed (Section 5.4).
- •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) Active bleeding or high risk for major bleeding (eg, gastrointestinal
- •pathology, malignancy with high risk of bleeding, active peptic ulcer).
- •(c) Need for chronic anticoagulation therapy (prophylactic doses of 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) Aspartate transaminase (AST) > 2.0 × ULN.
- •(b) Alanine transaminase (ALT) > 2.0 × ULN.
- •(c) Total bilirubin (TBL) > 1.5 x ULN (unless due to Gilbert*s syndrome).
- •(d) Platelet count < 100000 platelets/µl.
- •9 Blood pressure (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
- 另有 7 项未显示
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