Clinical trial NCT06298045: 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
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stable Angina
Keywords: Symptomatic Stable Angina
Adherence
prospective, international, non-interventional study
Quality of life
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female recently diagnosed symptomatic stable Angina patients.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of angina symptoms via the summary score of SAQ-7
timeFrame: from 2 weeks to 4 months
Secondary outcomes:
measure: CCS angina grading post-inclusion
timeFrame: from 2 weeks to 4 months
measure: Tolerance ( Adverse Events)
timeFrame: from 2 weeks to 4 months
measure: Tolerance ( Serious Adverse Events)
timeFrame: from 2 weeks to 4 months
measure: Adherence to the antianginal treatment combination under evaluation
timeFrame: from 2 weeks to 4 months
Other outcomes:
Locations:
city: Braşov
country: Romania
facility: Thera Card Srl
Study officials:
References: