Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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. 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).

        2. 4177 randomly selected participants receive only Minimal care as described above.

        3. 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.

      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)
    

Intervention name(s): PolyPill; Minimal care
Intervention type(s): Drug; Other
Intervention description(s): A combination tablet containing Aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily; Health education pamphlet on reducing cardiovascular risk factors, direct education on reducing cardiovascular risk factors provided by the study physician and the Community Health Worker, biannual follow-up and BP measurement
Other intervention name(s): PolyPill 4-1; PolyPill 4-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular Diseases; Drug Combinations; prevention and control; Aspirin; Antihypertensive Agents; Antilipemic Agents