Cardiovascular Diseases
Conditions
Keywords
Atorvastatin, Aspirin, nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, antihypertensive agents
Brief summary
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.
Detailed description
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.
Interventions
DRUGPolypill
Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg
Sponsors
Golestan University of Medical sciences
University of Birmingham
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Being enrolled in Golestan Cohort Study
Exclusion criteria
* Debilitating disease causing inability to comply * Contraindications to any of the components of PolyPill * Not consenting to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Events | 5 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in liver enzyme levels | 5 years | AST, ALT |
| Changes in liver stiffness | 5 years | As measured by fibroscan |
| Side effects | 5 years | questionnaire |
| Fat deposition | 5 years | Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT) |
| All-cause Mortality | 5 years | Yearly follow-up |
| Compliance | 5 years | Pill count |
Countries
Iran
Outcome results
None listed