One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease: An Open Label, Randomized, Multicenter Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Major Adverse Outcome Event (MACE)
研究概览
简要总结
Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers.
Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.
The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.
详细描述
Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers.
These drugs are usually given at different timetables. Recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted.
Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.
The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Ischemic heart disease, willing to participate, compliance to medical therapy
排除标准
- •Patients with acute coronary syndrome; pregnancy
研究组 & 干预措施
Once daily drug administration
Patients will be given cardiovascular drugs once daily
干预措施: Aspirin, Atorvastatin, Perindopril (Drug)
Twice daily drug administration
Patients will be given cardiovascular drugs twice daily
干预措施: Aspirin, Atorvastatin, Perindopril (Drug)
结局指标
主要结局
Major Adverse Outcome Event (MACE)
时间窗: Up to 1 year
The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
次要结局
未报告次要终点
研究者
Francesco Pelliccia
Professor
University of Roma La Sapienza