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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01245608

Collaborator

Golestan University of Medical Science (Other), University of Birmingham (Other)

2,400

Enrollment

Location

Arms

Actual Duration (Months)

28.9

Patients Per Site Per Month

Study Details

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

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 :

Oct 1, 2011

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Sep 1, 2018

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 Names: PolyPill 4-2
No Intervention: Control Only 6-monthly visits

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 Names:

PolyPill 4-2

No Intervention: Control

Only 6-monthly visits

Outcome Measures

Primary Outcome Measures

Major Cardiovascular Events [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

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