EUCTR2017-001502-15-AT进行中（未招募）1 期
Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts with Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging Study - PACMAN-AMI
Insel Gruppe AG - Inselspital, Universitätsklinik für Kardiologie0 个研究点目标入组 220 人开始时间: 2017年11月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •Acute myocardial infarction: acute ST-segment elevation myocardial infarction (STEMI) with pain onset within =24h, or non-ST segment elevation myocardial infarction (NSTEMI), with at least one coronary segment (culprit lesion) requiring PCI;
- •LDL-C =70 mg/dL (=1.8 mmol/L) assessed prior to, or during PCI in patients who have been receiving any stable statin regimen within = 4 weeks prior to enrollment; OR LDL-C =125 mg/dL (=3.2 mmol/L) in patients who are statin-naïve or have not been on stable statin regimen
- •for = 4 weeks prior to enrollment;
- •At least two major native coronary arteries (target vessels) each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure;
- •Hemodynamic stability allowing the repetitive administration of nitroglycerine;
- •Ability to understand the requirements of the study and to provide informed consent;
- •Willingness to undergo follow-up intracoronary imaging
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Left-main disease, defined as =50% reduction in lumen diameter of the left main coronary artery by angiographic visual estimation;
- •Three-vessel disease;
- •History of coronary artery bypass surgery;
- •TIMI flow <2 of the infarct-related artery after PCI;
- •Unstable clinical status (hemodynamic or electrical instability);
- •Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation;
- •Uncontrolled cardiac arrhythmia;
- •Severe renal dysfunction;
- •Active liver disease or hepatic dysfunction;
- •Known intolerance to rosuvastatin OR known statin intolerance ;
- •Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel;
- •Known sensitivity to any substances to be administered, including known statin intolerance
- •Patients who previously received alirocumab or other PCSK9 inhibitor;
- •Patient who received cholesterol ester transfer protein inhibitors in the
- •past 12 months prior to screening; Treatment with systemic steroids or
- •systemic cyclosporine in the past 3 months;
- •Known active infection or major hematologic, metabolic, or endocrine
- •dysfunction;
- •Planned surgery within 12 months;
- •Patients who will not be available for study-required visits;
- •Current enrollment in another investigational device or drug study;
- •History of cancer within the past 5 years, except for adequately treated
- •basal cell skin cancer, squamous cell skin cancer, or in situ cervical
- •Estimated life expectancy less than 1 year;
- •Female of childbearing potential (age <50 years and last menstruation
- •within the last 12 months), who did not undergo tubal ligation,
- •ovariectomy or hysterectomy.
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