Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Golestan University of Medical sciences | OTHER |
| University of Birmingham | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypill | Experimental | Single daily dose of PolyPill and 6-monthly visits |
|
| Control | No Intervention | Only 6-monthly visits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypill | Drug | Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | questionnaire | 5 years |
| Changes in liver enzyme levels | AST, ALT | 5 years |
Not provided
Inclusion Criteria:
- Being enrolled in Golestan Cohort Study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reza Malekzadeh, M.D. | Tehran University of Medical Sciences | Study Chair |
| Shahin Merat, M.D. | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golestan Cohort Center | Gonbad | Golestan Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19332502 | Background | Pourshams A, Khademi H, Malekshah AF, Islami F, Nouraei M, Sadjadi AR, Jafari E, Rakhshani N, Salahi R, Semnani S, Kamangar F, Abnet CC, Ponder B, Day N, Dawsey SM, Boffetta P, Malekzadeh R. Cohort Profile: The Golestan Cohort Study--a prospective study of oesophageal cancer in northern Iran. Int J Epidemiol. 2010 Feb;39(1):52-9. doi: 10.1093/ije/dyp161. Epub 2009 Mar 30. No abstract available. | |
| 25230980 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Changes in liver stiffness | As measured by fibroscan | 5 years |
| Compliance | Pill count | 5 years |
| Fat deposition | Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT) | 5 years |
| All-cause Mortality | Yearly follow-up | 5 years |
| Background |
| Ostovaneh MR, Poustchi H, Hemming K, Marjani H, Pourshams A, Nateghi A, Majed M, Navabakhsh B, Khoshnia M, Jaafari E, Mohammadifard N, Malekzadeh F, Merat S, Sadeghi M, Naemi M, Etemadi A, Thomas GN, Sarrafzadegan N, Cheng KK, Marshall T, Malekzadeh R. Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial. Eur J Prev Cardiol. 2015 Dec;22(12):1609-17. doi: 10.1177/2047487314550803. Epub 2014 Sep 17. |
| 35048107 | Derived | Merat S, Jafari E, Radmard AR, Khoshnia M, Sharafkhah M, Nateghi Baygi A, Marshall T, Shiravi Khuzani A, Cheng KK, Poustchi H, Malekzadeh R. Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver trial. Eur Heart J. 2022 Jun 1;43(21):2023-2033. doi: 10.1093/eurheartj/ehab919. |
| 26265520 | Derived | Merat S, Poustchi H, Hemming K, Jafari E, Radmard AR, Nateghi A, Shiravi Khuzani A, Khoshnia M, Marshall T, Malekzadeh R. PolyPill for Prevention of Cardiovascular Disease in an Urban Iranian Population with Special Focus on Nonalcoholic Steatohepatitis: A Pragmatic Randomized Controlled Trial within a Cohort (PolyIran - Liver) - Study Protocol. Arch Iran Med. 2015 Aug;18(8):515-23. |