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

Last updated: March 1, 2024
Sponsor: Servier Affaires Médicales
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Angina

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT06298045
DIM-06790-002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orCa-channel blocker) (according to CCS management guidelines 2019) and stillsymptomatic after initiation of this antianginal treatment.
  • Patient for whom the physician intends to prescribe trimetazidine based on her/hisdaily medical practice in the management of symptomatic Angina pectoris, respectingthe SmPC in force in the country. Such treatment decision must be taken independentlyfrom the participation of the patient in the study.
  • Evidence of a personally signed and dated informed consent document indicating thatthe patient (or a legally acceptable representative) has been informed of allpertinent aspects of the study.

Exclusion

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

Total Participants: 600
Study Start date:
July 15, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Thera Card Srl

    Braşov, 500091
    Romania

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.