Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study

Ministry of Health, Brazil

Status: Completed

Conditions: Stable Angina; Chronic Coronary Syndrome

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06464276

49351321.8.0000.0068

Details and patient eligibility

About

The objective of this non-interventional multicentric study (NIS) is to investigate the efficacy and tolerability of treatment with Vastarel Caps LP® in symptomatic patients with angina over 3 months under conditions of daily practice. The main questions it aims to answer are data collection on antianginal efficacy, symptom class, adherence, and overall tolerability in patients treated with Vastarel Caps LP®.

Patients diagnosed with chronic coronary syndrome and persistent stable angina, for whom the cardiologist chose to prescribe Trimetazidine 80mg once daily, were included in the study. Clinical information was collected in three distinct visits at baseline (V1), 1 month (V2), and 3 months (V3). During these visits, cardiologists collected the following variables based on a weekly occurrence: number of angina crises, short-acting nitrates (SAN) consumption, Canadian Cardiovascular Society (CCS) classification, level of self-reported daily physical activity, adherence, and tolerability to the treatment. Physical activity was measured using a scale from 1 to 10 (1 = no limitations, 5 = moderate limitations, and 10 = very marked limitations). Adherence was assessed by a previously validated six-item questionnaire. Assessment of therapy efficacy and tolerability were rated by the physician as "very satisfactory", "satisfactory", "not sufficiently satisfactory", and "unsatisfactory".

Full description

Patients must be informed about their participation in this study and the transfer of their clinical data outside the research center to statistical data analysts. The patient consent form must be obtained in writing. Patients diagnosed with chronic coronary syndrome and persistent stable angina, for whom the cardiologist chose to prescribe Trimetazidine 80mg once daily, were included in the study. Clinical information was collected in three distinct visits at baseline (V1), 1 month (V2), and 3 months (V3). During these visits, cardiologists collected the following variables based on a weekly occurrence: number of angina crises, short-acting nitrates (SAN) consumption, Canadian Cardiovascular Society (CCS) classification, level of self-reported daily physical activity, adherence, and tolerability to the treatment. Physical activity was measured using a scale from 1 to 10 (1 = no limitations, 5 = moderate limitations, and 10 = very marked limitations). Adherence was assessed by a previously validated six-item questionnaire. Assessment of therapy efficacy and tolerability were rated by the physician as "very satisfactory", "satisfactory", "not sufficiently satisfactory", and "unsatisfactory".

Enrollment: 800 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed Chronic Coronary Syndrome and persistent stable angina;
• Patients who are going to start using Vastarel Caps LP® as per their doctor's recommendation.

Exclusion criteria

• Hypersensitivity to the active ingredient or any of the excipients listed in Vastarel Caps LP®;
• Parkinson's disease, Parkinson's symptoms, tremors, restless leg syndrome, and other related movement disorders;
• Severe renal impairment (creatinine clearance <30 mL/min);
• Moderate renal impairment (creatinine clearance [30-60] mL/min).

Trial design

800 participants in 1 patient group

Patients with confirmed Chronic Coronary Syndrome and persistent stable angina.

Description:

Patients with confirmed Chronic Coronary Syndrome and persistent stable angina will be observed without any intervention, and the study will follow them for 3 months while they are treated with Trimetazidine 80 mg OD.

Treatment:

Other: No intervention