Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
试验速览
- 阶段
- 3 期
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- A composite clinical outcome of major adverse cardiovascular events (MACE)
研究概览
简要总结
Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized because of an acute myocardial infarction (STEMI/NSTEMI) and alive after discharge for at least 1 month
- •signing informed consent
- •clear indication of receiving all components of Polypill (aspirin, statin, ACE inhibitor/ARB, and beta blocker)
- •living in Isfahan city or nearby areas so that they can attend follow-ups
- •No mental illness limiting their self-care ability or Severe illness with an estimated lifespan of less than 3 years
- •No history of adverse reaction or contraindication to any component of the Polypill
- •Not having Secondary hyperlipidemia, serum creatinine ≥ 2, severe heart failure
- •No plan for a procedure (CABG, PCI, or another surgical procedures) within following 6 months
排除标准
- •Patient unlikely to complete trial
- •Need to change or discontinue any of the four principal drugs of the Polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea)
- •Severe illness with an estimated lifespan of less than 3 years
研究组 & 干预措施
Polypill
Polypill group will receive a fixed dose combinations of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg), prescribed once daily by moth for 34 months
干预措施: Polypill (Drug)
结局指标
主要结局
A composite clinical outcome of major adverse cardiovascular events (MACE)
时间窗: from time of randomization up to 34 months
MACE includes cardiac death, fatal/nonfatal MI or stroke, hospitalization due to acute coronary syndrome/acute cerebrovascular accident, revascularization procedures, development or worsening of HF, and development of persistent new AF.
次要结局
- cost-effectiveness of Polypill treatment compared with usual care(up to 34 months)
研究者
Masoumeh Sadeghi
Head of Cardiac Rehabilitation Research Center
Isfahan University of Medical Sciences