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

NCT06464276 | Completed

• 1 other identifier: 49351321.8.0000.0068
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Chronic Coronary Syndrome; Stable Angina

Keywords

Trimetazidine; Angina Pectoris; Stable Angina; Medication Adherence

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (3)

• Overall tolerability and adverse events (AE)/adverse drug reactions (ADR) in Vastarel Caps LP® therapy

  30 days (V2), 90 days (V3)

• Overall assessment by the physician of the efficacy of Vastarel Caps LP® therapy in symptomatic patients with angina.

  30 days (V2), 90 days (V3)

• Association of Vastarel Caps LP® efficacy according to the time since the patient's last revascularization.

  30 days (V2), 90 days (V3)

Study Arms (1)

Patients with confirmed Chronic Coronary Syndrome and persistent stable angina.

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with confirmed Chronic Coronary Syndrome and persistent stable angina.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable chronic angina who are considered eligible for treatment with Vastarel Caps LP® by their physicians are suitable for inclusion in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ministry of Health, Brazil: lead
• Servier: collaborator

Study Sites (1)

InCor Heart Institute

São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• Gowdak LHW, Dourado PMM, Precoma DB, de Oliviera Lopes Dusilek C, da Silva FM, Yugar-Toledo JC, Pena FM, de Almeida Gomes DA, do Espirito Santo Cestario E, Guimaraes OR Jr, Filho CRH, de Almeida CF, de Souza Brito F, Martins GF, Ferreira VRR, Flores MC, da Silva ML; V-GOOD Investigators. Effectiveness and Tolerability of Trimetazidine 80 mg Once Daily in Patients with Chronic Coronary Syndrome in Brazil: The V-GOOD Observational Study. Cardiol Ther. 2025 Jun;14(2):249-265. doi: 10.1007/s40119-025-00405-9. Epub 2025 Apr 29.

  PMID: 40299195 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Luis H Gowdak, PhD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 18, 2024
• Study Start: October 31, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

BR (1)