Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464276
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-06-07
Brief Title:
Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome The V-GOOD Study
Sponsor:
Ministry of Health Brazil
Organization:
Ministry of Health Brazil
Study Overview
Official Title:
Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome The V-GOOD Observational Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
V-GOOD
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None