Stable Angina
Conditions
Keywords
Symptomatic Stable Angina, Adherence, prospective, international, non-interventional study, Quality of life
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.
Interventions
None listed
Sponsors
Servier Affaires Médicales
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of angina symptoms via the summary score of SAQ-7 | from 2 weeks to 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CCS angina grading post-inclusion | from 2 weeks to 4 months | — |
| Tolerance ( Adverse Events) | from 2 weeks to 4 months | Number of patients with adverse events |
| Tolerance ( Serious Adverse Events) | from 2 weeks to 4 months | Number of patients with serious 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) |
Countries
Romania
Contacts
Primary ContactValerie Lehner
Outcome results
None listed