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

• Conditions: Chronic coronary heart disease (stable angina)

• Registration Number: EUCTR2004-001611-58-LT
• Lead Sponsor: JSC Grindeks

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the efficacy and safety of the treatment with mildronate in combination with standard therapy for the exercise tolerance of patients with stable angina pectoris;Secondary Objective: to assess the efficacy of mildronate on the symptoms of CHD, using the indices of exercise capacity for patients with stable angina;Primary end point(s): The change in exercise time in bicycle ergometry from baseline after 12 months treatment.