Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill (PolyIran)

• Time to first major cardiovascular event [ Time Frame: 5 years ] [ Designated as safety issue: No ]

  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
  
  

• Blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Changes in blood pressure after 5 years
  
  
• Fasting blood sugar, total cholesterol, HDL-C and LDL-C [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Changes in fasting blood sugar and lipid profile after 5 years
  
  
• Number of Subjects Developing Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  Number of participants who experience adverse effects to the PolyPill tablet leading to discontinuation.
  
  
• Compliance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Compliance is measured by pill-count in participants of the intervention arm as percent pills taken.
  
  
• Rate of major cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Number of major cardiovascular events (as described above) during 5 years
  
  

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:

1. 3500 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).
2. 3500 randomly selected participants receive only Minimal care as described above.
3. 24000 participants receive usual care (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).

Arms #1 and #2 are compared via a 2-armed open-labeled cluster Randomized Controlled Trial. Comparisons between arm #3 and the other 2 arms are also performed.

Endpoints include major cardiovascular events (death and hospitalization)