JPRN-jRCT2021200037进行中（未招募）2 期
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction. - GOLDILOX
Hibi Kazushige0 个研究点目标入组 84 人开始时间: 2020年12月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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
- >= 40age old 至 ot applicable（—）
- 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 providing signed informed consent, and must adhere to the schedules of activities.
- •2. Participant must be 40 years of age or more at the time of signing the informed consent form.
- •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 or more, 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 or more 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.
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 planned after screening. 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 in the past 3 months before enrollment
- •5. Ongoing New York Heart Association Class IV 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.
- •c. Need for chronic anticoagulation therapy.
- •d. Known severe liver disease.
- •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.
- •b. Ongoing atrial fibrillation or flutter.
- •c. Cancer within 5 years before randomization, with the exception of non melanoma skin cancer.
- •d. Alcohol or substance abuse within 6 months before randomization, 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.
- •9. BP values at screening:
- •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.
- •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 breath for at least 6 seconds.
- •11. Receipt of any investigational device or therapy within 6 months or 5 half lives before screening.
- •12. Planned participation in an additional study of an intervention or biologic before the end of the follow-up period.
- •13. Participants who are legally institutionalized.
- •14. An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative's role.
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