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

Stable Angina Clinical Trial

Official title:

Effectiveness and Impact on Quality of Life of a Combination of Trimetazidine With One Hemodynamic Agent (ß-blocker or Ca-channel Blocker), in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy: a Prospective, International, Non-interventional Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298045
• Other study ID #: DIM-06790-002
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Servier
• Contact: Valerie Lehner
• Phone: +33155726000
• Email: valerie.lehner[@]servier.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Locations

Country	Name	City	State
Romania	Thera Card Srl	Brasov

Sponsors (1)

Lead Sponsor	Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of angina symptoms via the summary score of SAQ-7		from 2 weeks to 4 months
Secondary	CCS angina grading post-inclusion		from 2 weeks to 4 months
Secondary	Tolerance ( Adverse Events)	Number of patients with adverse events	from 2 weeks to 4 months
Secondary	Tolerance ( Serious Adverse Events)	Number of patients with serious adverse events	from 2 weeks to 4 months
Secondary	Adherence to the antianginal treatment combination under evaluation	Adherence is measured by MARS-5 (a continuous variable)	from 2 weeks to 4 months