Status:
COMPLETED
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)
Lead Sponsor:
Servier Russia
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Brief 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 fi...
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 cl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05210465
Start Date
March 3 2022
End Date
April 17 2024
Last Update
April 18 2024
Active Locations (2)
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1
"Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo, Russia
2
Barbarash Olga Leonidovna
Moscow, Russia