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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of angina symptoms via the summary score of SAQ-7 | from 2 weeks to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| CCS angina grading post-inclusion | from 2 weeks to 4 months | |
| Tolerance ( Adverse Events) | Number of patients with adverse events | from 2 weeks to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female recently diagnosed symptomatic stable Angina patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Lehner | Contact | +33155726000 | valerie.lehner@servier.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thera Card Srl | Recruiting | Brasov | 500091 | Romania |
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| Tolerance ( Serious Adverse Events) | Number of patients with serious adverse events | from 2 weeks to 4 months |
| Adherence to the antianginal treatment combination under evaluation | Adherence is measured by MARS-5 (a continuous variable) | from 2 weeks to 4 months |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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