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)

NCT05210465 | Completed

• 1 other identifier: IC4-06795-067-RUS
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• To describe antianginal effectiveness of TMZ 80 mg OD in patients included in the study

  6 months

• To describe adherence to TMZ 80 mg OD in patients included in the study;

  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;

  6 months

• To describe impact on quality of life (QoL) to the treatment with TMZ 80 mg OD

  6 months

Study Arms (1)

patients with stable angina pectoris and prior MI

Other: speckle tracking mode of the stress ECHO test with dobutamine

Interventions

speckle tracking mode of the stress ECHO test with dobutamine OTHER

speckle tracking mode of the stress ECHO test with dobutamine

patients with stable angina pectoris and prior MI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with stable angina pectoris and prior MI in real clinical practice in Russia

You may qualify if:

• 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
• Intention to perform a stress echo with spackle tracking precedes the start of TMZ

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (2)

"Institute for Complex Issues of Cardiovascular Diseases"

Kemerovo, Russia

Location

Barbarash Olga Leonidovna

Moscow, Russia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: March 3, 2022
• Primary Completion: November 1, 2023
• Study Completion: April 17, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

RU (2)