Assessment of the efficacy and tolerability of Preductal OD and its influence on quality of life when added to bisoprolol in patients with stable angina
- Conditions
- Coronary artery diseaseCirculatory SystemCoronary Artery Disease
- Registration Number
- ISRCTN29992579
- Lead Sponsor
- Servier (Russia)
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34958427/ (added 30/12/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1939
1. Confirmed diagnosis of CAD, class II or III stable angina
2. Treatment with bisoprolol
3. Signed informed consent of a patient
4. No contraindications to the prescription of PREDUCTAL as indicated in the instruction for use of medicinal product for medical purposes
1. Age below 18 years
2. Class IV stable angina
3. Unstable angina
4. Myocardial infarction within 3 months prior to the inclusion in the program
5. Cerebrovascular accident (stroke of various cause; TIA) within 3 months prior to the inclusion in the program
6. Uncontrolled arterial hypertension (BP above 180 and 100 mm Hg), despite the current antihypertensive treatment.
7. Pregnancy, breastfeeding.
8. Inability to understand the nature of the program and follow the recommendations.
9. Presence of contraindications or known intolerance to trimetazidine.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured throughout the study using patient records (up to 3 months):<br> 1. Number of angina attacks per week<br> 2. Number of consumed short-acting nitroglycerin preparations per week.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. The rates of reported adverse events, including serious adverse events, were analyzed using patient records up to 3 months<br> 2. The quality of life of patients was evaluated according to the results of the EQ-5D-3L questionnaire and visual analogue scale (VAS) at baseline, 1 and 3-months<br>