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
| ISRCTN | ISRCTN29992579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29992579 |
| Secondary identifying numbers | № IC4-06795-051-RUS |
- Submission date
- 03/09/2021
- Registration date
- 08/09/2021
- Last edited
- 30/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Angina is chest pain caused by reduced blood flow to the heart muscles. It's not usually life threatening, but it's a warning sign that you could be at risk of a heart attack or stroke. With treatment and healthy lifestyle changes, it's possible to control angina and reduce the risk of these more serious problems.
The main medicines used to prevent angina attacks are:
beta blockers – to make the heart beat slower and with less force
calcium channel blockers – to relax the arteries, increasing blood supply to the heart muscle
Bisoprolol is a medicine used to treat high blood pressure (hypertension) and heart failure. If you have high blood pressure, taking bisoprolol helps prevent future heart disease, heart attacks and strokes. Bisoprolol is also used to prevent chest pain caused by angina.
Trimetazidine (Preductal) is a medicine used to prevent angina attacks.
The aim of this study was to evaluate the efficacy, tolerability, and also the influence on quality of life of the drug Preductal in patients with coronary artery disease (CAD) and angina pectoris during a 3-month treatment in combination with bisoprolol.
Who can participate?
Adult patients over 18 years of age with a confirmed diagnosis of stable angina.
What does the study involve?
Patients were treated in line with current recommendations for CCS management, which had to include receiving the maximal tolerated dose of bisoprolol. They could also be receiving a range of other cardiovascular drugs including calcium channel blockers, diuretics, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers, and imidazole receptor agonists. Follow up was 3 months.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Servier (Russia)
When is the study starting and how long is it expected to run for?
October 2017 to July 2018
Who is funding the study?
Servier (France)
Who is the main contact?
Prof. Yuriy Lopatin, yumlopatin@volgmed.ru
Contact information
Scientific
Head of the Cardiology Department No. 1 of the Volgograd Regional Clinical Cardiology Center
Volgograd
400138
Russian Federation
 ORCID ID |
0000-0003-1943-1137 |
|---|---|
| Phone | +9-917-330-55-98 |
| yumlopatin@volgmed.ru |
Study information
| Study design | Multicenter prospective open-label uncontrolled observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | 40366 PIS.docx |
| Scientific title | 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 |
| Study acronym | MODUS VIVENDI |
| Study hypothesis | The aim of the multicenter observational uncontrolled study was to evaluate 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. |
| Ethics approval(s) | Approved 14/12/2017, Local Institutional Ethics Committee (Moscow, Gagarinskiy st. 37/2, Russia; +8-916-260-76-64; ethicano@yahoo.com), ref: Protocol #11-17 |
| Condition | Coronary artery disease |
| Intervention | 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 Canadian Cardiovascular Society [CCS] classification). Patients were treated in line with current recommendations for CCS management, which had to include receiving the maximal tolerated dose of bisoprolol. Subjects were requested to make three visits to the study site: an inclusion visit (V1) at which patients were prescribed TMZ 80 mg once daily; 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Trimetazidine - Preductal OD 80mg (Vastarel OD 80mg) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 02/10/2017 |
| Overall study end date | 27/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 1939 |
| Participant 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 |
| Participant 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. |
| Recruitment start date | 24/12/2017 |
| Recruitment end date | 27/05/2018 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Moscow
117418
Russian Federation
Yaroslavl
150522
Russian Federation
St. Petersburg
197343
Russian Federation
Murmansk
183017
Russian Federation
Krasnodar
350089
Russian Federation
Nizhny Novgorod
603079
Russian Federation
Chelyabinsk
454021
Russian Federation
Novosibirsk
630129
Russian Federation
Sponsor information
Industry
Lesnaya st. 7
Moscow
125196
Russian Federation
| Phone | +7 495 9370700 |
|---|---|
| Yuriy.Burtsev@servier.com | |
| Website | http://www.servier.ru |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Servier Laboratories, Laboratoires Servier
- Location
- France
Results and Publications
| Intention to publish date | 30/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 08/09/2021 | No | Yes | ||
| Results article | 27/12/2021 | 30/12/2021 | Yes | No |
Additional files
Editorial Notes
30/12/2021: Publication reference added.
08/09/2021: Trial's existence confirmed by Local Institutional Ethics Committee (Moscow)
