Multicenter Observational Open Program. Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril in Patients With Arterial Hypertension and Stable CAD in Daily Clinical Practice (STYLE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,909
- 试验地点
- 1
- 主要终点
- The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline
研究概览
简要总结
Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice.
Type of the program: multicenter, observational, uncontrolled, open program. The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities.Each doctor includes four patients. It is planned to include not less than 1920 patients in total.
详细描述
Multicenter observational open program. Assessment of the efficacy and tolerability of the fixed-dose combination of bisoprolol/perindopril in patients with arterial hypertension and stable CAD in daily clinical practice (STYLE)
Study objectives and purposes:
Primary endpoints:
- efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP
- efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina
Secondary endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable CAD, defined as stable angina pectoris of class 1-3 by CCS (Canadian Cardiovascular Society) classification;
- •Previously or newly diagnosed essential hypertension
- •Age 18 to 79 years old;
- •Informed consent of the patient for participation in the program;
- •Decision of the doctor to prescribe bisoprolol/perindopril FDC before the inclusion in the program in accordance to the instruction for use.
排除标准
- •Stable angina pectoris, class 4;
- •History of myocardial infarction or cerebrovascular event within the past 3 months;
- •Unstable angina within the past 6 months;
- •Chronic heart failure classes 3-4 (NYHA);
- •Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus;
- •Any serious decompensated concomitant diseases requiring the regular medical therapy;
- •Inability to understand the essence of the program and follow the recommendations;
- •Contraindications to beta-blockers or ACE inhibitors using;
- •Participation of the patient in other trials in the present time or within 30 days before the start of observational program.
研究组 & 干预措施
the patients with HT and concomitant stable CAD
干预措施: bisoprolol/perindopril FDC (Drug)
结局指标
主要结局
The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline
时间窗: 3 months
Changes in the mean office systolic BP levels (in mm Hg) in the sitting position
Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks
时间窗: 3 month
Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC
Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position
时间窗: 3 months
Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position among the patints with HT and CAD recieving bis/perindopril FDC
Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels
时间窗: 3 month
The percentage of the patients achieved the target levels of clinical BP among included patients ( SBP \< 140 mm Hg and DBP \< 90 mm Hg) with HT and stable CAD recieving Bisoprolol/Perindopril FDC
次要结局
- Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS(3 month)
- Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice(3 month)