Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.

Cardiovascular Diseases Clinical Trial

— PolyIran-L  

Official title:

Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245608
• Other study ID #: 90-03-37-15582
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: September 2018

Study information

• Verified date: February 2018
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Polypill
Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg

Locations

Country	Name	City	State
Iran, Islamic Republic of	Golestan Cohort Center	Gonbad	Golestan

Sponsors (3)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Golestan University of Medical Science, University of Birmingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Side effects	questionnaire	5 years
Secondary	Changes in liver enzyme levels	AST, ALT	5 years
Secondary	Changes in liver stiffness	As measured by fibroscan	5 years
Secondary	Compliance	Pill count	5 years
Secondary	Fat deposition	Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT)	5 years
Secondary	All-cause Mortality	Yearly follow-up	5 years