Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill (PolyIran)

January 17, 2019 updated by: Tehran University of Medical Sciences

Fixed-dose Combination Therapy (PolyPill) in Primary and Secondary Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians

The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular diseases (myocardial infarction and stroke) are the most common cause of death and disability in Iran and account for nearly half of all-cause mortality in Iranians. Therefore, prevention of cardiovascular diseases is a top priority in countries with limited health system budgets such as Iran.

Eighty seven to hundred percent of patients dying from Coronary Heart Disease (CHD) have at least one risk factor for cardiovascular diseases. Therefore, risk factor modification in middle-aged and old individuals might prevent death and is a main priority. Combination drug therapy has been proposed as a cost-effective measure to reduce modifiable risk factors for cardiovascular disease in aged people. It has been showed that combination drug therapy can potentially decrease ischemic heart events and strokes by 88 and 80 percent, respectively.

The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.

This is a study on subjects older than 50 enrolled in the Golestan Cohort Study. The study is designed as a pragmatic cluster randomized trial. The study comprises three arms as follows:

  1. 4234 randomly selected participants receive PolyPill tablets once daily and Minimal care (which consists of direct education and pamphlet on cardiovascular risk reduction, biannual follow-ups and BP measurements).
  2. 4177 randomly selected participants receive only Minimal care as described above.
  3. Include remaining 24000 participants of rural participants of Golestan cohort, aged 50 and higher who receive the basic primary health care provided by the local physicians and Community Health Workers for the whole participants of Golestan Cohort study consistent with the current Iranian Health Care System guidelines. A random sample of 4395 subjects from this usual care arm were selected from this group as the third arm of the study and outcome ascertainment will be performed for this sample and will be used in the secondary comparison.

Arms #1 and #2 are compared via a 2-armed open-labeled cluster Randomized Controlled Trial. Comparisons between arm #3 and the other 2 arms are also performed.

Endpoints include major cardiovascular events (death and hospitalization)

Study Type

Interventional

Enrollment (Actual)

8410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50-79 years old
  • Enrollment in the Golestan Cohort Study

Exclusion Criteria:

  1. Hypersensitivity to any of PolyPill components:

    1. Hypersensitivity to Non-steroidal anti-inflammatory agents
    2. Hypersensitivity to statins
    3. Hypersensitivity to hydrochlorothiazide or sulfonamides
    4. Hypersensitivity to enalapril and valsartan
  2. Past medical history of angioedema
  3. Medical history of GI bleeding or peptic ulcer in the last 3 months
  4. Pregnancy or lactation
  5. Bleeding disorders such as hemophilia
  6. Receiving anticoagulation therapy
  7. Alcohol consumption greater than 40gr/week
  8. Advanced liver disease
  9. Uncontrolled seizures

  10. Asthma with any of the following criteria present:

    1. Daily symptoms
    2. Asthmatic attacks waking the patient from sleep more than once a week
    3. History of nasal polyps
    4. Aspirin sensitive asthma
    5. Presence of rhinitis symptoms not due to infection
  11. Past medical history of gout
  12. Serum creatinine values above 2 mg/dL or a Glomerular Filtration Rate (GFR) below 30 mL/min
  13. Hemoglobin concentrations below 11 g/dL for males and 10 g/dL for females
  14. BP < 90/60
  15. Debilitating medical/mental disorders affecting medication compliance (including psychosis, disabilities, and blindness)
  16. Past medical history of stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PolyPill
PolyPill once daily and Minimal Care
Drug: PolyPill
A combination tablet containing Aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily
Other Names:
  • PolyPill 4-2
  • PolyPill 4-1
Other: Minimal care
Health education pamphlet on reducing cardiovascular risk factors, direct education on reducing cardiovascular risk factors provided by the study physician and the Community Health Worker, biannual follow-up and BP measurement
Active Comparator: Minimal care
Minimal care.
Other: Minimal care
Health education pamphlet on reducing cardiovascular risk factors, direct education on reducing cardiovascular risk factors provided by the study physician and the Community Health Worker, biannual follow-up and BP measurement
No Intervention: Usual care
Basic primary health care provided by the local physicians and Community Health Workers consistent with the current Iranian Health Care System guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first major cardiovascular event
Time Frame: 5 years

Major cardiovascular events are defined as:

  1. Major coronary events include: sudden cardiac death, myocardial infarction, a diagnosis of angina, revascularization procedure
  2. Cerebrovascular accidents (CVA) including transient ischemic attacks (TIA)
  3. Hospitalization because of cardiovascular disease
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 5 years
Changes in blood pressure after 5 years
5 years
Fasting blood sugar, total cholesterol, HDL-C and LDL-C
Time Frame: 5 years
Changes in fasting blood sugar and lipid profile after 5 years
5 years
Number of Subjects Developing Adverse Events
Time Frame: 5 years
Number of participants who experience adverse effects to the PolyPill tablet leading to discontinuation.
5 years
Compliance
Time Frame: 5 years
Compliance is measured by pill-count in participants of the intervention arm as percent pills taken.
5 years
Rate of major cardiovascular events
Time Frame: 5 years
Number of major cardiovascular events (as described above) during 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

University of Birmingham
Golestan University of Medical Science

Investigators

  • Study Chair: Reza Malekzadeh, M.D., Digestive Disease Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDRC.89.17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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