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

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ClinicalTrials.gov Identifier: NCT01245608
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Golestan University of Medical Science
University of Birmingham
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Polypill Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Actual Study Start Date : October 2011
Actual Primary Completion Date : January 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Polypill
Single daily dose of PolyPill and 6-monthly visits
 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
Other Name: PolyPill 4-2
No Intervention: Control
Only 6-monthly visits


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245608


Locations
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Iran, Islamic Republic of
Golestan Cohort Center
Gonbad, Golestan, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Golestan University of Medical Science
University of Birmingham
Investigators
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Study Chair: Reza Malekzadeh, M.D. Tehran University of Medical Sciences
Principal Investigator: Shahin Merat, M.D. Tehran University of Medical Sciences
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01245608    
Other Study ID Numbers: 90-03-37-15582
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tehran University of Medical Sciences:
Atorvastatin
Aspirin
nonalcoholic steatohepatitis
nonalcoholic fatty liver disease
antihypertensive agents
Additional relevant MeSH terms:
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Cardiovascular Diseases