NCT05210465Completed
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)
Source: ClinicalTrials.gov · Last updated 18 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 36 (actual)
- First submitted
- 14 Jan 2022
- Start date
- Mar 2022
- Primary completion date
- Nov 2023
- Lead sponsor
- Servier Russia
- Diseases
- Coronary artery disease
- NCT number
- NCT05210465
What you commit to
- Study type: Observational
- Participants enrolled: 36
- From Mar 2022 to the primary completion date, Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute cerebrovascular event (stroke of various origins, transient ischemic attack) within 6 months before screening date
Other illness
- 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
- Angina pectoris of IV functional CCS class
- Heart failure IV functional class by NYHA
- Cardiac valves insufficiency with regurgitation of stage III and higher
- Myocardial infarction less than 6 months from the inclusion date
- Uncontrolled arterial hypertension of stage 3 (blood pressure above 180/100 mm Hg) despite ongoing antihypertensive therapy
Lab values
- Known severe or moderate renal impairment (creatinine clearance \<60 ml / min).
- 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
Age
- Age over 75 years or under 18 years old
Other
- Pregnancy, breastfeeding
- Any contraindications to stress echocardiography with dobutamine
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| "Institute for Complex Issues of Cardiovascular Diseases" Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| Barbarash Olga Leonidovna Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.