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

Ministry of Health, Brazil1 个研究点分布在 1 个国家目标入组 800 人开始时间: 2021年10月31日最近更新: 2024年6月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 800
试验地点: 1
主要终点: Effect of Vastarel Caps LP® therapy on frequency of angina episodes.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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".

详细描述

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".

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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).