Mildronate-efficacy and safety in treatment for chronic coronary heart disease (stable angina) - II - MILSS II

JSC Grindeks0 个研究点目标入组 300 人开始时间: 2004年12月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Written informed consent.
•Age over 18 years.
•At least 3 months prior to the study history of stable effort angina II-III functional class according to classification of CCS.
•Myocardial ischaemia with typical ST - changes (horizontal or down sloping ST-depresion = 1 mm) as the limiting factor of exercise in bicycle ergometry at least on visits 3 and 4.
•Willingness to comply with the standard 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) yes
•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 or its ingredients.
•Inability to perform bicycle ergometry test.
•Myocardial infarction, stroke or unstable angina within 3 months prior to the study and during the screening period.
•Hemodynamically significant valvular heart disease.
•Sustained ventricular tachycardia, supraventricular tachycardia, ventricular flutter or fibrillation within 3 months prior to the study.
•Over 20 % difference in the exercise time between the last two exercise tests of the run-in period.
•Exercise time less than 3 or more than 13 minutes in bicycle ergometry at visit 4.
•Serious changes of ECG, making impossible correct interpretation of bicycle ergometry results.
•Any medical condition making the patient unsuitable for the study.

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