Condition category
Circulatory System
Date applied
23/03/2018
Date assigned
27/04/2018
Last edited
17/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria GLEZER

ORCID ID

Contact details

Department of Preventive and Emergency Cardiology
Sechenov First Moscow State Medical University
2-4 Bolshaya Pirogovskaya st.
Moscow
119991
Russian Federation
+7 (0)985 7630420
287ast@mail.ru

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evidence for the antianginal efficacy of trimetazidine in patients with stable angina in daily practice

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

Inter-University Ethics Committee, 23/10/2014, 09-14 dd Moscow

Study design

Multicentre open-label prospective observational study

Primary study design

Observational

Secondary study design

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Not Applicable

Drug names

Trimetazidine

Primary outcome measures

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 trial start date

01/09/2014

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

896

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

Trial participating centre

Sechenov First Moscow State University
Department of Preventive and Emergency Cardiology
Moscow
119991
Russian Federation

Sponsor information

Organisation

Servier

Sponsor details

7
Lesnaya st.
Moscow
125047
Russian Federation
+7 (0)495 9370700
irina.elyubaeva@servier.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Servier

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/04/2017

Participant level data

Available on request

Results - basic reporting

The study included 896 patients: 54% women, aged 29–90 years (42.6% [65 years), 63% with class II angina, and receiving beta-blockers alone or in combination (93%). Add-on TMZ reduced angina frequency and short-acting nitrate use within 2 weeks (both p<0.0001) regardless of background therapy and maintained this effect over 6 months. It increased the proportion of patients with class I angina sixfold while decreasing that of class 3 angina almost fourfold. It also improved walking distance and well-being at 6 months (both p<0.0001). Treatment was well tolerated.

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28220388
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29766461

Publication citations

Additional files

Editorial Notes

17/05/2018: Publication reference added.