Clinical trial NCT06464276: Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
Official title: Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Coronary Syndrome
Stable Angina
Keywords: Trimetazidine
Angina Pectoris
Stable Angina
Medication Adherence
Lead sponsor: Ministry of Health, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Servier
First posted: 2024-06-18
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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".

Detailed 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".

Eligibility criteria: 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).

Primary outcomes:
measure: Effect of Vastarel Caps LP® therapy on frequency of angina episodes.
timeFrame: 30 days (V2), 90 days (V3)
measure: Effect of Vastarel Caps LP® therapy on the use of sublingual nitrates.
timeFrame: 30 days (V2), 90 days (V3)
measure: Effect of Vastarel Caps LP® therapy on symptom class (CCS class).
timeFrame: 30 days (V2), 90 days (V3)
measure: Effect of Vastarel Caps LP® therapy on daily activity.
timeFrame: 30 days (V2), 90 days (V3)
measure: Influence of Vastarel Caps LP® therapy on patient adherence.
timeFrame: 30 days (V2), 90 days (V3)
Secondary outcomes:
measure: Overall tolerability and adverse events (AE)/adverse drug reactions (ADR) in Vastarel Caps LP® therapy
timeFrame: 30 days (V2), 90 days (V3)
measure: Overall assessment by the physician of the efficacy of Vastarel Caps LP® therapy in symptomatic patients with angina.
timeFrame: 30 days (V2), 90 days (V3)
measure: Association of Vastarel Caps LP® efficacy according to the time since the patient's last revascularization.
timeFrame: 30 days (V2), 90 days (V3)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: InCor Heart Institute
Study officials:
affiliation: InCor Heart Institute
name: Luis H Gowdak, PhD
role: PRINCIPAL_INVESTIGATOR
References: