EUCTR2014-005462-30-HU进行中（未招募）1 期
A multiple dose, dose-finding, placebo controlled, double blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and evaluate the efficacy, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome event - MILANO DRIVE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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.Male or female subjects greater than or equal to 18 years of age
- •2.Have experienced a recent ACS event within 14 days of randomization that requires a clinically indicated coronary angiogram
- •3.A qualifying ACS event is defined as a spontaneous MI:
- •A diagnosis of a qualifying MI event will be defined by abnormal levels of cardiac biomarkers (troponin I or T or creatinine kinase-myocardial isoenzyme band [CK-MB] mass) with at least one determination greater than the 99th percentile or upper limits of normal for the laboratory and at least one of the following:
- •Chest discomfort or symptoms of myocardial ischemia (greater than or equal to 10 minutes) at rest within 24 hours prior to hospitalization for MI
- •New electrocardiogram (ECG) findings (or presumed new if no prior ECG available) indicative of acute myocardial ischemia in absence of left ventricular hypertrophy and left bundle branch block (LBBB) as listed:
- •-New or presumed new ST depression greater than 0.5 millimeters (mm) in two contiguous leads or T-wave inversion greater than 1 mm in leads with predominant R wave or R/S greater than 1mm in two contiguous leads
- •-New or presumed new ST elevation at the J point in =2 contiguous leads with the cut-off points: =0.2 mV in men or =0.15mV in women in leads V2-V3 and/or =0.1 mV in other leads or new or presumed new LBBB
- •-New tall R wave >40 ms in V1, V2 and R/S =1 in V1 with concordant positive T-wave in the absence of a conduction defect
- •-New Q waves =30 ms wide and >1mm deep in any 2 leads of a contiguous lead grouping or Q wave >20 ms or QS complex in leads V2 and V3 (These criteria also apply to silent MI detected during a routine follow-up visit)
- •Loss of viable myocardium based on imaging evidence of new or presumed new wall motion or perfusion deficit (eg, echocardiography, left ventriculography during cardiac catheterization radionuclide angiography, single-photon emission tomography, magnetic resonance imaging)
- •4.Baseline coronary angiogram must meet all of the following criteria for IVUS interrogation of Target Artery:
- •TARGET ARTERY:
- •Must be accessible to the IVUS catheter
- •Must have a stenotic area of =20% and <50% in lumen diameter by angiographic visual estimation within the length of the native coronary artery (target segment”) for imaging by IVUS
- •The target artery has not undergone prior percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
- •The target artery is not currently a candidate for intervention or a likely candidate for intervention over the treatment phase of the study and until the second IVUS interrogation at Day 36
- •The target artery may not be a bypass graft
- •The target artery may not be the culprit vessel for a previous MI TARGET ARTERY MAY HAVE:
- •A lesion of up to 60% stenosis, distal to the target segment, provided that this area is not a target for PCI or CABG
- •A single branch of the target vessel” may have a narrowing less than or equal to 70% by visual estimation, provided that the branch in question is not a target for PCI or CABG
- •5.Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1.Baseline IVUS not completed due to non-qualifying coronary angiogram as demonstrated by:
- •Greater than 50% reduction in lumen of the left main coronary artery by visual estimation
- •Extensive CAD with no target vessel for IVUS interrogation
- •2.Baseline IVUS interrogation determined to be unacceptable by the Atherosclerosis Imaging Core Laboratory
- •3.Clinically significant heart disease which, in the opinion of the investigator, is likely to require CABG, PCI, cardiac transplantation, and surgical or percutaneous valve repair and/or replacement following index IVUS imaging (does not apply to PCI that occurs as a result of initial screening angiogram and completed prior to index IVUS imaging)
- •4.New York Heart Association class III or IV heart failure or last known left ventricular ejection fraction less than 30%
- •5.Coronary artery bypass surgery less than 6 weeks prior to the qualifying IVUS
- •6.Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication
- •7.Uncontrolled severe hypertension: systolic blood pressure greater than 180 mmHg or diastolic blood pressure > 110 mmHg prior to randomization despite antihypertensive therapy
- •8.Poorly controlled diabetes mellitus and an HbA1c greater than 10.0% prior to randomization
- •9.Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR unexplained alanine aminotransferase, aspartate aminotransferase, elevation greater than 2 × ULN OR total bilirubin elevation greater than1.5 × ULN at screening confirmed by a repeat measurement at least 1 week apart
- •10.Fasting triglyceride value less than 400 mg/deciliter (dL)
- •11.Impaired kidney function defined as calculated glomerular filtration rate less than 60 milliliter (mL)/min by Modification of Diet in Renal Disease formula. In addition, subjects with a 0.3 mg/dL or 25% increase in serum creatinine in the initial 3 to 5 days from presentation for ACS will be excluded from the study
- •12.Serious comorbid disease in which the life expectancy of the subject is shorter than the duration of the trial (eg, acute systemic infection, cancer, or other serious illnesses). This includes all cancers with the exception of treated basal-cell carcinoma occurring greater than 3 years before screening
- •13.Body weight greater than 120 kg or less than 20 kg
- •14.Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, intrauterine device or tubal ligation). Women who are greater than 2 years postmenopausal (defined as greater than or equal to 1 year since last menstrual period) AND if less than 55 years old with a negative pregnancy test within 24 hours of randomization or surgically sterile are exempt from this exclusion
- •15.Men who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide)
- •16.Previous participation in this study or any preceding study with ETC-216, MDCO-216, or similar investigational medicines containing apolipoprotein A-I (ApoA-I) proteins
- •17.Known allergy to the phospholipid or any other component of the investigational product (dimeric rApoA-IM, 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, or mannitol and sucrose in phosphate buffer).
- •18.Treatment with other investigational medicinal products or devices within 30
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