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

Evaluation of the efficacy, tolerability, and also the influence on quality of life of the drug Preductal OD, 80 mg sustained-release capsules (JSC Servier, Russia) in patients with coronary artery disease (CAD) and angina pectoris during a 3-month treatment in combination with bisoprolol in an outpatient setting

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN29992579

Enrollment

2000

Registered

2021-09-08

Start date

2017-12-24

Completion date

Unknown

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease Circulatory System Coronary Artery Disease

Interventions

General practitioners and cardiologists with outpatient practices included adult patients >18 years of age with a confirmed diagnosis of stable angina (defined as class II-III angina according to the

a 1-month follow-up visit (V2)

and a 3-month follow-up visit (V3). At each visit the following information was collected: data on number of angina attacks and number of short-acting nitrate doses taken (based on patient diary)

quality-of-life assessments using the EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) questionnaire and a visual analoganalogue scale (VAS)

and assessment of medication adherence. Information on spontaneously reported adverse drug reactions or events was collected at the V2 and V3 visits.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Measured throughout the study using patient records (up to 3 months): 1. Number of angina attacks per week 2. Number of consumed short-acting nitroglycerin preparations per week.	—

Secondary

Measure	Time frame
1. The rates of reported adverse events, including serious adverse events, were analyzed using patient records up to 3 months 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	—

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026