Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Major Cardiovascular Events
研究概览
简要总结
The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50.
Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.
详细描述
2400 subjects will be randomly selected from participants of the Golestan Cohort Study (GCS) who are living in Gonbad and are over 50 years old. These subjects will be randomized to either receive PolyPill or no treatment.
Those agreeing to the study will undergo additional measurements (in addition to the baseline measurements performed in the GCS) including liver-related tests such as liver enzyme levels, abdominal ultrasonography and liver stiffness measurement. Some additional tests such as color doppler ultrasonography of carotid vessels will also be performed.
Subjects in the PolyPill arm who have no contraindication for the components of the pill will receive a single daily dose of PolyPill for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being enrolled in Golestan Cohort Study
排除标准
- •Debilitating disease causing inability to comply
- •Contraindications to any of the components of PolyPill
- •Not consenting to the study
研究组 & 干预措施
Polypill
Single daily dose of PolyPill and 6-monthly visits
干预措施: Polypill (Drug)
结局指标
主要结局
Major Cardiovascular Events
时间窗: 5 years
The first occurrence of hospitalization for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden death, new-onset heart failure, coronary artery revascularization procedures and stroke (fatal or non-fatal).
次要结局
- Changes in liver enzyme levels(5 years)
- Fat deposition(5 years)
- All-cause Mortality(5 years)
- Side effects(5 years)
- Changes in liver stiffness(5 years)
- Compliance(5 years)