Antianginal efficacy of trimetazidine in daily practice
| ISRCTN | ISRCTN65209863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65209863 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/03/2018
- Registration date
- 27/04/2018
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Angina is caused by narrowing of the arteries that supply the heart. Angina causes pain or discomfort that happens when the heart can't get enough blood and oxygen during physical activity or extreme emotion. Angina is common and affects more than 100 million people in the world. Several types of medicines are used to prevent or reduce angina, but the disease is not always well controlled and some patients remain affected and their daily activity can be limited even with treatment.
Who can participate?
Men and women who had stable angina for at least 3 months and were having symptoms despite treatment for angina.
What does the study involve?
All participants took trimetazidine twice daily as well as their other angina medicine.
What are the possible benefits and risks of participating?
The participants might benefit from better control of their angina symptoms (eg reduced pain). The risks of participating include the possibility of side effects to trimetazidine. To reduce risk from participation, doctors monitored patients closely and were empowered to change medication depending on symptoms and side effects. Patients were only included in the study if the doctor thought they might benefit from trimetazidine treatment. Patients were involved in reporting their health status and walking distance assessment and this might give them a more active role in the treatment and monitoring of their angina, which can lead to a more positive outlook and better quality of life. More frequent testing and visits during this study ensured closer monitoring of the effectiveness and tolerability of trimetazidine.
Where is the study run from?
The study was run from the Department of Preventive and Emergency Cardiology, Sechenov First Moscow State University, Moscow, Russia.
When is the study starting and how long is it expected to run for?
The study started in September 2014 and ended in September 2015.
Who is funding the study?
Servier (Russia)
Who is the main contact?
Prof. Maria Glezer
287ast@mail.ru
Contact information
Scientific
Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University, 2-4 Bolshaya Pirogovskaya st.
Moscow
119991
Russian Federation
| Phone | +7 (0)985 7630420 |
|---|---|
| 287ast@mail.ru |
Study information
| Study design | Multicentre open-label prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evidence for the antianginal efficacy of trimetazidine in patients with stable angina in daily practice |
| Study acronym | CHOICE-2 |
| Study hypothesis | The guidelines recommend a beta-blocker or calcium channel blocker as the first-line medication for angina, supplemented by other agents for additional symptoms. One such agent is trimetazidine (TMZ), which has been shown to reduce the frequency of anginal episodes and improve exercise performance without affecting haemodynamic parameters. However, extensive real-world evidence for its efficacy in combination with first-line therapies has been lacking. |
| Ethics approval(s) | Inter-University Ethics Committee, 23/10/2014, 09-14 dd Moscow |
| Condition | Stable angina |
| Intervention | Trimetazidine 35 mg bid was added to antianginal therapy by investigators according to the medical merit and necessity of therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Trimetazidine |
| Primary outcome measure | Angina frequency and short-acting nitrate use over the 6 months, assessed using patient's diary at baseline, week 2, and months 2, 4, and 6 |
| Secondary outcome measures | 1. Walking distance eliciting angina assessed using patient's diary at baseline, week 2, and months 2, 4, and 6. The distance was recorded by patients in diary as the distance they walked (in m) before experiencing angina symptoms, in conditions of daily activity, when they walked at their own pace and on mostly flat surfaces. 2. Patient self-reported well-being on a visual analog scale from 0 (very good) to 100 (very bad) at baseline, week 2, and months 2, 4, and 6. |
| Overall study start date | 01/09/2014 |
| Overall study end date | 01/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 896 |
| Total final enrolment | 741 |
| Participant inclusion criteria | 1. Aged >18 years 2. Provided informed consent 3. ≥3-month history of stable angina documented by ECG-confirmed myocardial ischaemia and/or prior myocardial infarction, revascularisation or >50% coronary stenosis, and treated for CAD in the past month. 4. Inclusion was decided solely by physicians according to the medical merit and necessity of treatment with TMZ 35 mg bid |
| Participant exclusion criteria | 1. Canadian Cardiovascular Society (CCS) class 4 stable angina 2. Hospitalisation in the past 3 months for acute coronary syndrome (infarction or unstable angina) 3. Uncontrolled hypertension (systolic >180 mmHg or diastolic >100 mmHg) despite ongoing antihypertensive treatment 4. New York Heart Association (NYHA) class III or IV heart failure 5. Pregnancy or breastfeeding 6. CAD surgery scheduled in the next 6 months 7. Severe hepatic or renal failure, or other severe chronic disease requiring continuous treatment 8. Known poor treatment compliance 9. Intolerance or contraindications to TMZ. |
| Recruitment start date | 01/03/2015 |
| Recruitment end date | 30/04/2015 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Moscow
119991
Russian Federation
Sponsor information
Industry
7, Lesnaya st.
Moscow
125047
Russian Federation
| Phone | +7 (0)495 9370700 |
|---|---|
| irina.elyubaeva@servier.com | |
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | Yes | No | |
| Results article | results | 01/07/2018 | Yes | No | |
| Other publications | post hoc analysis of trimetazidine in combination with bisoprolol | 01/11/2020 | 30/11/2020 | Yes | No |
Editorial Notes
30/11/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the 2018 reference.
17/05/2018: Publication reference added.
