Chronic Coronary SyndromeV-GOODNCT06464276
Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
An observational study of Chronic Coronary Syndrome and Stable Angina, run by Ministry of Health, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Coronary Syndrome, Stable Angina
- How many people
- 800 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Oct 2021to 30 Sep 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Observational Study
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".
Read the 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".
- Conditions
- Chronic Coronary Syndrome, Stable Angina
- Being tested
- No intervention
- Keywords
- Trimetazidine, Angina Pectoris, Stable Angina, Medication Adherence
- Medical subject headings
- Angina, Stable, Angina Pectoris, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days (V2), 90 days (V3)
Secondary outcomes (3)
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."
Measured: 30 days (V2), 90 days (V3)
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."
Measured: 30 days (V2), 90 days (V3)
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.
Measured: 30 days (V2), 90 days (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start31 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Brazil
- Sponsor type
- Other government
- Collaborators
- Servier
- Responsible party
- Principal investigator, Luis Henrique W Gowdak, MD, PhD, Ministry of Health, Brazil
- Investigators
- Luis H Gowdak, PhD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464276
- Sponsor's protocol ID
- 49351321.8.0000.0068
- Acronym
- V-GOOD
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40299195
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Observational Study
- ClinicalTrials.gov ID
- NCT06464276
- Acronym / sponsor ID
- V-GOOD / 49351321.8.0000.0068
- Conditions
- Chronic Coronary Syndrome, Stable Angina
- Keywords
- Trimetazidine, Angina Pectoris, Stable Angina, Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Ministry of Health, BrazilOther government
- Collaborators
- Servier
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed Chronic Coronary Syndrome and persistent stable angina. | – | Other: No interventionPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with confirmed Chronic Coronary Syndrome and persistent stable angina. |
Primary outcome
Effect of Vastarel Caps LP® therapy on frequency of angina episodes.
Time frame: 30 days (V2), 90 days (V3)
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.
Effect of Vastarel Caps LP® therapy on the use of sublingual nitrates.
Time frame: 30 days (V2), 90 days (V3)
Assessment of the effect of Vastarel Caps LP® therapy on the alteration of sublingual nitrates consumption at 30 days and 90 days.
Effect of Vastarel Caps LP® therapy on symptom class (CCS class).
Time frame: 30 days (V2), 90 days (V3)
Assessing the impact of Vastarel Caps LP® therapy on modifying symptom classification using the CCS class at 30 and 90 days.
Effect of Vastarel Caps LP® therapy on daily activity.
Time frame: 30 days (V2), 90 days (V3)
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.
Influence of Vastarel Caps LP® therapy on patient adherence.
Time frame: 30 days (V2), 90 days (V3)
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.
3 secondary outcomes
Overall tolerability and adverse events (AE)/adverse drug reactions (ADR) in Vastarel Caps LP® therapy
Time frame: 30 days (V2), 90 days (V3)
Overall assessment by the physician of the efficacy of Vastarel Caps LP® therapy in symptomatic patients with angina.
Time frame: 30 days (V2), 90 days (V3)
Association of Vastarel Caps LP® efficacy according to the time since the patient's last revascularization.
Time frame: 30 days (V2), 90 days (V3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 40299195Gowdak 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.
Related trials for Chronic Coronary Syndrome
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis H Gowdak, PhD principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome and Stable Angina, run by Ministry of Health, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Vastarel Caps LP® therapy on frequency of angina episodes. (time frame: 30 days (V2), 90 days (V3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.