Health Condition 1: I208- Other forms of angina pectoris
Conditions
Interventions
None listed
Sponsors
Servier Affaires Médicales
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female recently diagnosed symptomatic stable Angina patients is equals to Patients presenting with typical angina or angina equivalent with evidence of myocardial ischaemia ST segment changes on ECG regional myocardial dysfunction at echocardiography regional perfusion defect etc Canadian Cardiovascular Society class II or III as well as patients with angina at rest vasospastic angina 2 Age morethan 18 years old or the age of the majority in the concerned country 3 Inclusion of patients into this non interventional study is exclusively determined by the decision of the physician regarding medical meaningfulness and rationale of treatment with the combination under evaluation in the study 4 Patient already treated by only one first line antianginal haemodynamic agent beta blocker or Calcium channel blocker according to CCS management guidelines 2019 and still symptomatic within two to four weeks after initiation of this antianginal treatment. At inclusion SAQ 7 Angina Frequency score should be lessthan 60 5 Patient for whom the physician intends to prescribe trimetazidine based on her or 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
Exclusion criteria: 1 Any contra-indication to trimetazidine according to SmPC hypersensitivity to the active substance or to any of the excipients Parkinson disease parkinsonian symptoms, tremors, restless leg syndrome and other related movement disorders severe renal impairment creatinine clearance lessthan 30ml per min. 2 Patients already treated by trimetazidine before entry into the study. 3 Patients needing another antianginal treatment than the combination assessed within the study (one hemodynamic agent beta blocker or Calcium channel blocker with one metabolic agent ie trimetazidine. 4 Previous and current acute coronary syndrome (including any unstable angina: angina at rest which lasts more than 20 min and crescendo angina). 5 Previous coronary revascularization by CABG or PCI for either acute coronary syndrome or stable ischaemic heart disease. 6 Presence of heart failure, left ventricular hypertrophy, valve disease, dilated or hypertrophic cardiomyopathy, myocarditis, pericarditis, endocarditis, chronic arrythmias or other cardiac vascular condition requiring pharmacological treatment. 7 Presence of symptomatic anemia. 8 Planned revascularization. 9 Life expectancy lessthan 1 year. 10 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 (which represents an integration of the patients physical limitation, angina symptoms and quality of life), at 4 months post-inclusion.Timepoint: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adherence (MARS-5 (continuous variable)) to the antianginal treatment combination under evaluation at 2 weeks, 1 month and 4 months post-inclusion.Timepoint: 2 weeks, 1 month and 4 months post-inclusion.;- Adherence (MARS-5 (continuous variable)) to the other medications taken during the study in case of co-morbidities, at 2 weeks, 1 month and 4 months post-inclusion.Timepoint: 2 weeks, 1 month and 4 months post-inclusion.;- Assessment of angina symptoms on different patients’ subgroups (e.g. according to co-morbidities such as diabetes, …) via the summary score of SAQ-7, at 2 weeks, 1 month and 4 months post-inclusion.Timepoint: 1 month and 4 months post-inclusion.;- Incidence of revascularization during the study. If applicable, evaluation of angina persistence and/or ischemia after revascularisation during the study will also be assessed (prevalence of symptomatic patients, CCS angina grading and SAQ-7 at the next visit(s) following revascularization if any).Timepoint: 4 months;- Tolerance (e.g., AEs, SAE (categorical variables) to the antianginal treatment combination under evaluation at 2 weeks, 1 month and 4 months post-inclusion.Timepoint: 2 weeks, 1 month and 4 months post-inclusion.;Assessment of angina symptoms via the summary score of SAQ-7 (which represents an integration of the patients physical limitation, angina symptoms and quality of life), at 2 weeks and 1-month post-inclusion Timepoint: 2 weeks and 1-month post-inclusion ;Baseline characteristics of the population of patients included in the study, the co-morbidities and their evolution during the study.Timepoint: 4 months;CCS angina grading at 2 weeks, 1 month and 4 months post-inclusion. Timepoint: 2 weeks, 1 month and 4 months post-inclusion. ;Need of antianginal treatment upgrading during the study. Timepoint: 4 month;Patients and physicians satisfaction concerning the combination of treatment under evaluation at 2 weeks, 1 month and 4 months post-inclusion. Timepoint: 2 weeks, 1 m | — |
Countries
Brazil, Egypt, India, Malaysia, Romania
Contacts
Public ContactDr Ritesh Khandelwal
Servier India Private Limited
Outcome results
None listed