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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,400
Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg
Golestan Cohort Center
Gonbad, Golestan Province, Iran
Major Cardiovascular Events
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).
Time frame: 5 years
Side effects
questionnaire
Time frame: 5 years
Changes in liver enzyme levels
AST, ALT
Time frame: 5 years
Changes in liver stiffness
As measured by fibroscan
Time frame: 5 years
Compliance
Pill count
Time frame: 5 years
Fat deposition
Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT)
Time frame: 5 years
All-cause Mortality
Yearly follow-up
Time frame: 5 years
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