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Completed

NCT Number: NCT01245608

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

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.

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Key information

Conditions

Cardiovascular Diseases Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Golestan Cohort Center

Gonbad, Golestan Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: PolyPill 4-2

Primary outcomes

  1. Major Cardiovascular Events

    Time frame: 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 outcomes

  1. Side effects

    Time frame: 5 years

    questionnaire

  2. Changes in liver enzyme levels

    Time frame: 5 years

    AST, ALT

  3. Changes in liver stiffness

    Time frame: 5 years

    As measured by fibroscan

  4. Compliance

    Time frame: 5 years

    Pill count

  5. Fat deposition

    Time frame: 5 years

    Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT)

  6. All-cause Mortality

    Time frame: 5 years

    Yearly follow-up

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Golestan University of Medical sciences
  • University of Birmingham

Registry information

Official study title

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

Acronym: PolyIran-L

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2010
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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