NL-OMON50428已完成3 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 - Inselspital0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- •- Male or female, age *18 years at screening
- •- 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:
- •- Angiographic evidence of <50% reduction in lumen diameter by angiographic
- •visual estimation
- •- Target vessel deemed to be accessible to imaging catheters and suitable for
- •intracoronary imaging in the proximal (50mm) segment (*target segment*)
- •- Target vessel may not be a bypass (saphenous vein or arterial) graft or a
- •bypassed native vessel
- •- Target vessel must not have undergone previous PCI within the target segment
- •- Target vessel is not candidate for intervention at the time of qualifying PCI
- •or over the following 6 months in the judgment of the Investigator
- •- Hemodynamic stability allowing the repetitive administration of nitroglycerine
- •- Ability to understand the requirements of the study and to provide informed
- •- Willingness to undergo follow-up intracoronary imaging
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, defined as *70% reduction in lumen diameter of three
- •major epicardial coronary arteries by angiographic visual estimation or in
- •major branches of one or more of these arteries, irrespective of the
- •localization (proximal 50mm or more distal localization) of the obstructive
- •- 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, defined as recurrent and symptomatic
- •ventricular tachycardia or atrial fibrillation with rapid ventricular response
- •not controlled by medications in the past 3 months prior to screening
- •- Severe renal dysfunction, defined by estimated glomerular filtration rate <30
- •ml/min/1.73m2
- •- Active liver disease or hepatic dysfunction;
- •- Known intolerance to rosuvastatin OR
- •Known statin intolerance defined by the following criteria: inability to
- •tolerate at least 2 different statins (one statin at the lowest starting
- •average daily dose and the other statin at any dose); intolerance associated
- •with confirmed, intolerable statin-related adverse effect(s) or significant
- •biomarker abnormalities; symptom or biomarker changes resolution or significant
- •improvement upon dose decrease or discontinuation; and symptoms or biomarker
- •changes not attributable to established predispositions such as drug-drug
- •interactions and recognized conditions increasing the risk of 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 in the judgment of the Investigator
- •- Planned surgery within 12 months
- •- Patients who will not be available for study-required visits in the judgment
- •of the Investigator
- •- 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 cancer
- •- 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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