Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy

Recruiting

• Conditions: Stable Angina

• Registration Number: NCT06298045
• Lead Sponsor: Servier Affaires Médicales

Brief Summary

The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-15
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Male and female recently diagnosed symptomatic stable Angina patients
• Age ≥18 years old
• Patient already treated by one first line antianginal haemodynamic agent (ß-blocker or Ca-channel blocker) (according to CCS management guidelines 2019) and still symptomatic after initiation of this antianginal treatment.
• Patient for whom the physician intends to prescribe trimetazidine based on her/his daily medical practice in the management of symptomatic Angina pectoris, respecting the SmPC in force in the country. Such treatment decision must be taken independently from the participation of the patient in the study.
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

• Any contra-indication to trimetazidine according to SmPC
• Patient already treated with trimetazidine before entry into the study.
• Pregnancy or intention to become pregnant or lactating women during the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of angina symptoms via the summary score of SAQ-7	from 2 weeks to 4 months

Secondary Outcome Measures

Name	Time	Method
CCS angina grading post-inclusion	from 2 weeks to 4 months
Tolerance ( Serious Adverse Events)	from 2 weeks to 4 months	Number of patients with serious adverse events
Tolerance ( Adverse Events)	from 2 weeks to 4 months	Number of patients with adverse events
Adherence to the antianginal treatment combination under evaluation	from 2 weeks to 4 months	Adherence is measured by MARS-5 (a continuous variable)

Trial Locations

Locations (1)

Thera Card Srl; 🇷🇴 Braşov, Romania