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

Stable Angina Clinical Trial

— V-GOOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06464276
• Other study ID #: 49351321.8.0000.0068
• Status: Completed
• Start date: October 31, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2024
• Source: Ministry of Health, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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".

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Coronary Syndrome
• Stable Angina
• Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Brazil	InCor Heart Institute	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Brazil	Servier

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Vastarel Caps LP® therapy on frequency of angina episodes.	Assessment of the effect of Vastarel Caps LP® therapy on changing the number of angina attacks at 30 and 90 days, as reported by the patient.	30 days (V2), 90 days (V3)
Primary	Effect of Vastarel Caps LP® therapy on the use of sublingual nitrates.	Assessment of the effect of Vastarel Caps LP® therapy on the alteration of sublingual nitrates consumption at 30 days and 90 days.	30 days (V2), 90 days (V3)
Primary	Effect of Vastarel Caps LP® therapy on symptom class (CCS class).	Assessing the impact of Vastarel Caps LP® therapy on modifying symptom classification using the CCS class at 30 and 90 days.	30 days (V2), 90 days (V3)
Primary	Effect of Vastarel Caps LP® therapy on daily activity.	Assessment of the impact of Vastarel Caps LP® therapy on adjusting the daily activity threshold at 30 and 90 days, utilizing the Functional Assessment Scale to be answered by the patient.	30 days (V2), 90 days (V3)
Primary	Influence of Vastarel Caps LP® therapy on patient adherence.	Assessment of the impact of Vastarel Caps LP® therapy on enhancing patient adherence at 30 and 90 days, through the following questions: This morning, did you forget to take Vastarel Caps LP? Yes or No, Since our last appointment, have you taken Vastarel Caps LP after the usual time? Yes or No and Since our last appointment, have you ever forgotten to take Vastarel Caps LP? Yes or No.	30 days (V2), 90 days (V3)
Secondary	Overall tolerability and adverse events (AE)/adverse drug reactions (ADR) in Vastarel Caps LP® therapy	Assessment of the effect of Vastarel Caps LP® therapy on overall patient tolerability and the occurrence of adverse events (AE)/adverse drug reactions (ADR), as reported by the patient through the following question: "How do you assess the overall tolerability of Vastarel Caps LP therapy in this patient? Very satisfactory, Satisfactory, Not satisfactory enough, or Unsatisfactory."	30 days (V2), 90 days (V3)
Secondary	Overall assessment by the physician of the efficacy of Vastarel Caps LP® therapy in symptomatic patients with angina.	Assessment of the efficacy of Vastarel Caps LP® therapy based on the physician's overall evaluation through the following question: "How do you assess the overall effectiveness of Vastarel Caps LP therapy in this patient? Very satisfactory, Satisfactory, Not satisfactory enough, or Unsatisfactory."	30 days (V2), 90 days (V3)
Secondary	Association of Vastarel Caps LP® efficacy according to the time since the patient's last revascularization.	Assessment of the relationship between the time elapsed since the last surgical intervention to enhance blood flow in the coronary arteries and the effectiveness of Vastarel treatment.	30 days (V2), 90 days (V3)