Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.
- Registration Number
- NCT01245608
- Lead Sponsor
- Tehran University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2400
- Being enrolled in Golestan Cohort Study
- Debilitating disease causing inability to comply
- Contraindications to any of the components of PolyPill
- Not consenting to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polypill Polypill Single daily dose of PolyPill and 6-monthly visits
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Changes in liver enzyme levels 5 years AST, ALT
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
Side effects 5 years questionnaire
Changes in liver stiffness 5 years As measured by fibroscan
Compliance 5 years Pill count
Trial Locations
- Locations (1)
Golestan Cohort Center
🇮🇷Gonbad, Golestan, Iran, Islamic Republic of