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

NCT06298045 | Recruiting

• 1 other identifier: DIM-06790-002
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina

Keywords

Symptomatic Stable Angina; Adherence; prospective, international, non-interventional study; Quality of life

Outcome Measures

Primary Outcomes (1)

• Assessment of angina symptoms via the summary score of SAQ-7

  from 2 weeks to 4 months

Secondary Outcomes (4)

• CCS angina grading post-inclusion

  from 2 weeks to 4 months

• Tolerance ( Adverse Events)

  from 2 weeks to 4 months

• Tolerance ( Serious Adverse Events)

  from 2 weeks to 4 months

• Adherence to the antianginal treatment combination under evaluation

  from 2 weeks to 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female recently diagnosed symptomatic stable Angina patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (1)

Thera Card Srl

Brasov, 500091, Romania

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valerie Lehner

CONTACT

+33155726000; valerie.lehner@servier.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: July 15, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

RO (1)