Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables. (PolyIran-L)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.|
- Major Cardiovascular Events [ Time Frame: 5 years ] [ Designated as safety issue: No ]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).
- Side effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Changes in liver enzyme levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Changes in liver stiffness [ Time Frame: 5 years ] [ Designated as safety issue: No ]As measured by fibroscan
- Compliance [ Time Frame: 5 years ] [ Designated as safety issue: No ]Pill count
- Fat deposition [ Time Frame: 5 years ] [ Designated as safety issue: No ]Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT)
- All-cause Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Single daily dose of PolyPill and 6-monthly visits
Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg
Other Name: PolyPill 4-2
No Intervention: Control
Only 6-monthly visits
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245608
|Iran, Islamic Republic of|
|Golestan Cohort Center|
|Gonbad, Golestan, Iran, Islamic Republic of|
|Study Chair:||Reza Malekzadeh, M.D.||Tehran University of Medical Sciences|
|Principal Investigator:||Shahin Merat, M.D.||Tehran University of Medical Sciences|