A placebo-controlled, double-blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and to evaluate the efficacy, pharmacokinetics, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome. - MILANO PILOT

The Medicines Company0 个研究点目标入组 120 人2015年9月16日

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简要总结

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注册库

who.int

开始日期

2015年9月16日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

The Medicines Company

入排标准

入选标准

•1\) Male or female subjects \= 18 years of age.
•2\) Have experienced a recent ACS event within 14 days of screening that requires a clinically indicated coronary angiogram.
•3\) A qualifying ACS event will be defined as follows:
•A diagnosis of a qualifying MI event will be defined by abnormal levels of cardiac biomarkers (troponin I or T or 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 (\= 10 minutes) at rest within 24 hours prior to hospitalization for MI.
•New ECG findings (or presumed new if no prior ECG available) indicative of acute myocardial ischemia in absence of left ventricular hypertrophy (LVH) and left bundle branch block (LBBB) as listed:
•oNew or presumed new ST depression greater than 0\.5 mm in 2 contiguous leads or T wave inversion greater than 1mm in leads with predominant R wave or R/S greater than 1 in 2 contiguous leads.
•oNew 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.
•oNew 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.
•oNew Q waves \= 30 ms wide and \> 1mm deep in any 2 leads of a contiguous lead grouping or Q wave \>20ms or QS complex in leads V2 and V3 (These criteria also apply to silent MI detected during a routine follow\-up visit).

排除标准

•1\) Baseline IVUS not completed due to non\-qualifying coronary angiogram as demonstrated by:
•a) Greater than 50% reduction in lumen of the left main coronary artery by visual estimation.
•b) Extensive CAD with no target vessel for IVUS interrogation.
•2\) Baseline IVUS interrogation determined to be unacceptable by the Atherosclerosis Imaging Core Laboratory (AICL).
•3\) Previous STEMI within the last 90 days (not including qualifying ACS event)
•4\) Clinically significant heart disease which, in the opinion of the Investigator, is likely to require CABG, PCI cardiac transplantation, 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).
•5\) New York Heart Failure Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \< 30%.
•6\) Coronary artery bypass surgery \< 6 weeks prior to the qualifying IVUS.
•7\) Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication.
•8\) Uncontrolled severe hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg prior to randomization despite anti\-hypertensive therapy.