Mildronate - Efficacy And Safety Of Treatment For Chronic Coronary Heart Disease (Stable Angina) I - MILSS I

Joint Stock Company Grindeks0 个研究点开始时间: 2008年6月10日最近更新: 2012年3月19日

试验速览

暂无简介。

•Written informed consent;
•Age over 18 years;
•At least 3 months history prior to the study of stable effort angina II-III functional class according to classification of CCS verified either by:
•- previous myocardial infarction or
•- coronary angiography, or
•- precutaneous coronary angioplastics, or
•- caronary artery by-pass surgery, or
•- exercise test with typical findings of myocardial ischemia;
•Myocardial ischemia with ST-changes (horizontal or down sloping ST-depression >/=1mm) as the limiting factor of exercise in bicycle ergometry at least on visits 3 and 4;
•Willingness to comply with the standart antianginal therapy after visit 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Known intolerance of Mildronate preparation or its ingredients;
•Inability to perform bicycle ergometry test;
•Extreme obesity (body mass index >35kg/m2
•Myocardial infarction, stroke or unstable angina within 3 months prior to the study and during the screening period;
•Coronary revascularization within 3 months prior to the study;
•Congestive heart failure class III-IV according to classification of NYHA;
•Hemodynamically significant valvular heart disease;
•Hemodynamically significant congenital heart disease;
•Acute myocarditis;
•Unischemic cardiomiopathia;
•Pericarditis;
•Cor pulmonale;
•Heart rate <50 or >100bpm at rest;
•Systolic blood preasure (sBP) <100mmHg or >180mmHg or diastolic blood preasure (dBP) <70mmHg or >110mmHg;
•Treatment with mildronate within 6 months prior to the study;
•Premenopausal females not using a medically accepted method of birth control;
•Pregnant or breastfeeding women;

发起方

Joint Stock Company Grindeks