Effectiveness of Polypill for Primary Prevention of Cardiovascular Disease (PolyPars): Study Design and Rationale for a Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 4,415
- 试验地点
- 1
- 主要终点
- Major Cardiovascular Events (MCVE)
研究概览
简要总结
The purpose of this study is to determine the effects of a fixed dose combination of enalapril (or valsartan), with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in participants of Pars Cohort of Iran.
详细描述
Cardiovascular diseases (CVDs) are the most common causes 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 CVDs have at least one risk factor for cardiovascular diseases. Therefore, risk factor modification 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. It has been showed that combination drug therapy can potentially decrease ischemic heart events and strokes by 88 and 80 percent, respectively.
The study is designed as a pragmatic cluster randomized controlled trial. The purpose of this study is to determine the effects of a fixed dose combination of either enalapril or valsartan, with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50. Two formulations of Polypill tablets were used. The first formulation (Polypill-E) contained enalapril 5 mg. If participants developed cough, they were switched by a trained physician to Polypill-V, containing valsartan 40 mg instead of enalapril.
The investigators have previously tested the same combination in a different setting in Golestan, Northeast of Iran. The results of the study were published in the Lancet. The current study enrolls participants of Pars Cohort running in Fars province, southern Iran, aged above 50. A total of 4415 participants (91 clusters) were recruited following inclusion and exclusion criteria. The study comprises two arms as follows:
2200 randomly selected participants receive PolyPill tablets once daily and minimal care (which consists of direct education and pamphlet on cardiovascular risk reduction).
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 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 Pars Cohort Study
排除标准
- •Not consenting to participate in the study
- •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 regular 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
- •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 mmHg
- •Debilitating medical/mental disorders affecting compliance (including psychosis, disabilities, and blindness)
- •Past medical history of stroke
研究组 & 干预措施
PolyPill
Single daily dose of PolyPill and minimal care.
干预措施: PolyPill (Drug)
结局指标
主要结局
Major Cardiovascular Events (MCVE)
时间窗: 5 years
the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions.
次要结局
- Level of blood pressure (mmHg)(5 years)
- Level of total cholesterol (mg/dL)(5 years)
- Level of HDL (mg/dL)(5 years)
- Level of LDL (mg/dL)(5 years)
- Level of triglycerides (mg/dL)(5 years)
- Level of fasting blood sugar (mg/dL)(5 years)
- Number of Subjects Developing Adverse Events(5 years)
- Compliance(5 years)
- Non cardiovascular mortality(5 years)