Coronary Artery DiseaseMETHODNCT05210465
Objective Confirmation of thе Anti-ischemic Effectiveness of Trimetazidine 80mg Once Daily in Patients With Stable Angina Who Had a History of Myocardial Infarction (METHOD)
An observational study of Coronary Artery Disease, run by Servier Russia at 2 sites in Russia.
Trial summary
METHOD is a prospective observational program that will be conducted in 1centre of the Russian Federation. Prospective follow-up will be for about 6 months. The METHOD study is a 2 visit study with first visit of inclusion and second visit of completion of the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- speckle tracking mode of the stress ECHO test with dobutamine
- How many people
- 36 participants
- Where
- 2 sitesRussia
- Study dates
- 3 Mar 2022to 17 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: patients with stable angina pectoris and prior MI in real clinical practice in Russia
Who may be able to join
- Age older than 18 yearsAge older than 18 years
- Signed informed consent form
- Stable angina pectoris (CCS I-III FC) with signs of myocardial ischemia despite treatment with antianginal drug(s) present either clinically and/ or at stress ECHO test with dobutamine
- History of myocardial infraction occurred 6 months and more from the inclusion date
- Trimetazidine (TMZ) is recommended as add on to the current antianginal treatment and this recommendation precedes inclusion of a patient in the study
- Intention to perform a stress echo with spackle tracking precedes the start of TMZ
- Physician's intention to perform a stress ECHO test within a 6-month period after the date of inclusion in the study
Who cannot join
- Age over 75 years or under 18 years old
- Hypersensitivity to the active substance or any excipient specified in SmPc of TMZ 80 mg OD
- Parkinson's disease, parkinsonism symptoms, tremors, restless legs syndrome and other accompanying movement disorders
- Known severe or moderate renal impairment (creatinine clearance <60 ml / min).
- Angina pectoris of IV functional CCS class
- Heart failure IV functional class by NYHA
Show all 13Show fewer
- Cardiac valves insufficiency with regurgitation of stage III and higher
- Myocardial infarction less than 6 months from the inclusion date
- Acute cerebrovascular event (stroke of various origins, transient ischemic attack) within 6 months before screening date
- Uncontrolled arterial hypertension of stage 3 (blood pressure above 180/100 mm Hg) despite ongoing antihypertensive therapy
- Fructose / sucrose intolerance, presence of glucose-galactose malabsorption syndrome, sucrose-somaltase deficiency and other enzymopathies associated with intolerance to sucrose, which is part of the drug
- Pregnancy, breastfeeding
- Any contraindications to stress echocardiography with dobutamine
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
"Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo
Barbarash Olga Leonidovna
Moscow
About this study
METHOD is a prospective observational program that will be conducted in 1centre of the Russian Federation. Prospective follow-up will be for about 6 months. The METHOD study is a 2 visit study with first visit of inclusion and second visit of completion of the study. Patients with stable angina pectoris eligible to the study inclusion criteria will be invited to participate in this observational program. The parameters for analysis will be collected by doctors and entered into CRF. The final analysis will include data from patients who were taking TMZ 80 mg OD during the observational period. The decision to stop the study will be made once 36 patients receiving treatment with trimetazidine 80 mg OD will have been evaluated at V1.
It is expected that 5 cardiologists will participate in the program. The planned number of patients is 36.
Read the detailed description
To describe antiischemic and antianginal effectiveness of trimetazidine OD 80 mg as well as adherence to the treatment with TMZ 80 mg OD in patients with stable angina pectoris and prior MI in real clinical practice in Russia
- Conditions
- Coronary Artery Disease
- Being tested
- speckle tracking mode of the stress ECHO test with dobutamine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking mode of the stress ECHO test with dobutamineOther
speckle tracking mode of the stress ECHO test with dobutamine
| Study group | Role | What they receive |
|---|---|---|
| patients with stable angina pectoris and prior MI | Not described Receives: Other: speckle tracking mode of the stress ECHO test with dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe antiischemic effectiveness of TMZ 80 mg OD assessed by the speckle tracking mode of the stress ECHO test with dobutamine in patients included in the study.
Measured: 6 months
Secondary outcomes (4)
To describe antianginal effectiveness of TMZ 80 mg OD in patients included in the study
Measured: 6 months
To describe adherence to TMZ 80 mg OD in patients included in the study;
Measured: 6 months
To describe correlations between adherence (low, medium or high) to the treatment with TMZ 80 mg OD and antiischemic and antianginal effectiveness of TMZ 80 mg OD in patients included in the study;
Measured: 6 months
To describe impact on quality of life (QoL) to the treatment with TMZ 80 mg OD
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start3 Mar 2022
- Primary completion1 Nov 2023
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210465
- Sponsor's protocol ID
- IC4-06795-067-RUS
- Acronym
- METHOD
- Status last verified
- Apr 2024
- First submitted
- 14 Jan 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kvasnikov BB, Barbarash OL, Polikutina OM, Burtsev YP. Trimetazidine's Anti-ischemic Effectiveness in Patients with Stable Angina with Prior Myocardial Infarction Evaluated via Stress Echocardiography with Speckle Tracking: METHOD study. Cardiol Ther. 2026 Jun;15(2):171-184. doi: 10.1007/s40119-026-00447-7. Epub 2026 Apr 29.
PubMed 42056447
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Confirmation of thе Anti-ischemic Effectiveness of Trimetazidine 80mg Once Daily in Patients With Stable Angina Who Had a History of Myocardial Infarction (METHOD)
- ClinicalTrials.gov ID
- NCT05210465
- Acronym / sponsor ID
- METHOD / IC4-06795-067-RUS
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
METHOD is a prospective observational program that will be conducted in 1centre of the Russian Federation. Prospective follow-up will be for about 6 months. The METHOD study is a 2 visit study with first visit of inclusion and second visit of completion of the study. Patients with stable angina pectoris eligible to the study inclusion criteria will be invited to participate in this observational program. The parameters for analysis will be collected by doctors and entered into CRF. The final analysis will include data from patients who were taking TMZ 80 mg OD during the observational period. The decision to stop the study will be made once 36 patients receiving treatment with trimetazidine 80 mg OD will have been evaluated at V1.
It is expected that 5 cardiologists will participate in the program. The planned number of patients is 36.
Detailed description
To describe antiischemic and antianginal effectiveness of trimetazidine OD 80 mg as well as adherence to the treatment with TMZ 80 mg OD in patients with stable angina pectoris and prior MI in real clinical practice in Russia
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with stable angina pectoris and prior MI | – | Other: speckle tracking mode of the stress ECHO test with dobutamine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with stable angina pectoris and prior MI in real clinical practice in Russia
Key inclusion criteria (7 listed)
- Age older than 18 yearsAge older than 18 years
- Signed informed consent form
- Stable angina pectoris (CCS I-III FC) with signs of myocardial ischemia despite treatment with antianginal drug(s) present either clinically and/ or at stress ECHO test with dobutamine
- History of myocardial infraction occurred 6 months and more from the inclusion date
- Trimetazidine (TMZ) is recommended as add on to the current antianginal treatment and this recommendation precedes inclusion of a patient in the study
Key exclusion criteria (13 listed)
- Age over 75 years or under 18 years old
- Hypersensitivity to the active substance or any excipient specified in SmPc of TMZ 80 mg OD
- Parkinson's disease, parkinsonism symptoms, tremors, restless legs syndrome and other accompanying movement disorders
- Known severe or moderate renal impairment (creatinine clearance <60 ml / min).
- Angina pectoris of IV functional CCS class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speckle tracking mode of the stress ECHO test with dobutaminespeckle tracking mode of the stress ECHO test with dobutamine | Other | patients with stable angina pectoris and prior MI |
Primary outcome
To describe antiischemic effectiveness of TMZ 80 mg OD assessed by the speckle tracking mode of the stress ECHO test with dobutamine in patients included in the study.
Time frame: 6 months
4 secondary outcomes
To describe antianginal effectiveness of TMZ 80 mg OD in patients included in the study
Time frame: 6 months
To describe adherence to TMZ 80 mg OD in patients included in the study;
Time frame: 6 months
To describe correlations between adherence (low, medium or high) to the treatment with TMZ 80 mg OD and antiischemic and antianginal effectiveness of TMZ 80 mg OD in patients included in the study;
Time frame: 6 months
To describe impact on quality of life (QoL) to the treatment with TMZ 80 mg OD
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 42056447Kvasnikov BB, Barbarash OL, Polikutina OM, Burtsev YP. Trimetazidine's Anti-ischemic Effectiveness in Patients with Stable Angina with Prior Myocardial Infarction Evaluated via Stress Echocardiography with Speckle Tracking: METHOD study. Cardiol Ther. 2026 Jun;15(2):171-184. doi: 10.1007/s40119-026-00447-7. Epub 2026 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Servier Russia at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe antiischemic effectiveness of TMZ 80 mg OD assessed by the speckle tracking mode of the stress ECHO test with dobutamine in patients included in the study. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05210465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.