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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 : Active, not recruiting
First Posted : November 22, 2010
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated 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.
Study Start Date : October 2011
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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 ]
  2. Changes in liver enzyme levels [ Time Frame: 5 years ]
  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 ]

Eligibility Criteria

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

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

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

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
Study Chair: Reza Malekzadeh, M.D. Tehran University of Medical Sciences
Principal Investigator: Shahin Merat, M.D. Tehran University of Medical Sciences
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01245608     History of Changes
Other Study ID Numbers: DDRI/90.22
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tehran University of Medical Sciences:
nonalcoholic steatohepatitis
nonalcoholic fatty liver disease
antihypertensive agents

Additional relevant MeSH terms:
Cardiovascular Diseases