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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Assessment of angina symptoms via the summary score of SAQ-7
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of angina symptoms via the summary score of SAQ-7
时间窗: from 2 weeks to 4 months
次要结局
- CCS angina grading post-inclusion(from 2 weeks to 4 months)
- Tolerance ( Serious Adverse Events)(from 2 weeks to 4 months)
- Tolerance ( Adverse Events)(from 2 weeks to 4 months)
- Adherence to the antianginal treatment combination under evaluation(from 2 weeks to 4 months)