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

Conditions: Chronic coronary heart disease (stable angina)

Registration Number: EUCTR2007-005179-32-LV

Lead Sponsor: Joint Stock Company Grindeks

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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;