Fixed-dose Combination Therapy (PolyPill) in Primary and Secondary Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,410
- 试验地点
- 1
- 主要终点
- Time to first major cardiovascular event
研究概览
简要总结
The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.
详细描述
Cardiovascular diseases (myocardial infarction and stroke) are the most common cause of death and disability in Iran and account for nearly half of all-cause mortality in Iranians. Therefore, prevention of cardiovascular diseases is a top priority in countries with limited health system budgets such as Iran.
Eighty seven to hundred percent of patients dying from Coronary Heart Disease (CHD) have at least one risk factor for cardiovascular diseases. Therefore, risk factor modification in middle-aged and old individuals might prevent death and is a main priority. Combination drug therapy has been proposed as a cost-effective measure to reduce modifiable risk factors for cardiovascular disease in aged people. It has been showed that combination drug therapy can potentially decrease ischemic heart events and strokes by 88 and 80 percent, respectively.
The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.
This is a study on subjects older than 50 enrolled in the Golestan Cohort Study. The study is designed as a pragmatic cluster randomized trial. The study comprises three arms as follows:
- 4234 randomly selected participants receive PolyPill tablets once daily and Minimal care (which consists of direct education and pamphlet on cardiovascular risk reduction, biannual follow-ups and BP measurements).
- 4177 randomly selected participants receive only Minimal care as described above.
- Include remaining 24000 participants of rural participants of Golestan cohort, aged 50 and higher who receive the basic primary health care provided by the local physicians and Community Health Workers for the whole participants of Golestan Cohort study consistent with the current Iranian Health Care System guidelines. A random sample of 4395 subjects from this usual care arm were selected from this group as the third arm of the study and outcome ascertainment will be performed for this sample and will be used in the secondary comparison.
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
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-79 years old
- •Enrollment in the Golestan Cohort Study
排除标准
- •Hypersensitivity to any of PolyPill components:
- •Hypersensitivity to Non-steroidal anti-inflammatory agents
- •Hypersensitivity to statins
- •Hypersensitivity to hydrochlorothiazide or sulfonamides
- •Hypersensitivity to enalapril and valsartan
- •Past medical history of angioedema
- •Medical history of GI bleeding or peptic ulcer in the last 3 months
- •Pregnancy or lactation
- •Bleeding disorders such as hemophilia
- •Receiving anticoagulation therapy
- •Alcohol consumption greater than 40gr/week
- •Advanced liver disease
- •Uncontrolled seizures
- •Asthma with any of the following criteria present:
- •Daily symptoms
- •Asthmatic attacks waking the patient from sleep more than once a week
- •History of nasal polyps
- •Aspirin sensitive asthma
- •Presence of rhinitis symptoms not due to infection
- •Past medical history of gout
- •Serum creatinine values above 2 mg/dL or a Glomerular Filtration Rate (GFR) below 30 mL/min
- •Hemoglobin concentrations below 11 g/dL for males and 10 g/dL for females
- •BP < 90/60
- •Debilitating medical/mental disorders affecting medication compliance (including psychosis, disabilities, and blindness)
- •Past medical history of stroke
研究组 & 干预措施
PolyPill
PolyPill once daily and Minimal Care
干预措施: PolyPill (Drug)
PolyPill
PolyPill once daily and Minimal Care
干预措施: Minimal care (Other)
Minimal care
Minimal care.
干预措施: Minimal care (Other)
结局指标
主要结局
Time to first major cardiovascular event
时间窗: 5 years
Major cardiovascular events are defined as: 1. Major coronary events include: sudden cardiac death, myocardial infarction, a diagnosis of angina, revascularization procedure 2. Cerebrovascular accidents (CVA) including transient ischemic attacks (TIA) 3. Hospitalization because of cardiovascular disease
次要结局
- Blood pressure(5 years)
- Fasting blood sugar, total cholesterol, HDL-C and LDL-C(5 years)
- Number of Subjects Developing Adverse Events(5 years)
- Compliance(5 years)
- Rate of major cardiovascular events(5 years)