Prevention of Cardiovascular Disease With Polypill Among Pars Cohort Participants

February 5, 2021 updated by: Tehran University of Medical Sciences

Effectiveness of Polypill for Primary Prevention of Cardiovascular Disease (PolyPars): Study Design and Rationale for a Pragmatic Cluster Randomized Controlled Trial

The purpose of this study is to determine the effects of a fixed dose combination of enalapril (or valsartan), with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in participants of Pars Cohort of Iran.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular diseases (CVDs) are the most common causes 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 CVDs have at least one risk factor for cardiovascular diseases. Therefore, risk factor modification 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. It has been showed that combination drug therapy can potentially decrease ischemic heart events and strokes by 88 and 80 percent, respectively.

The study is designed as a pragmatic cluster randomized controlled trial. The purpose of this study is to determine the effects of a fixed dose combination of either enalapril or valsartan, with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50. Two formulations of Polypill tablets were used. The first formulation (Polypill-E) contained enalapril 5 mg. If participants developed cough, they were switched by a trained physician to Polypill-V, containing valsartan 40 mg instead of enalapril.

The investigators have previously tested the same combination in a different setting in Golestan, Northeast of Iran. The results of the study were published in the Lancet. The current study enrolls participants of Pars Cohort running in Fars province, southern Iran, aged above 50. A total of 4415 participants (91 clusters) were recruited following inclusion and exclusion criteria. The study comprises two arms as follows:

2200 randomly selected participants receive PolyPill tablets once daily and minimal care (which consists of direct education and pamphlet on cardiovascular risk reduction).

2215 randomly selected participants receive only minimal care as described above.

Endpoints include major cardiovascular events (MCVE).

Study Type

Interventional

Enrollment (Actual)

4415

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 Pars Cohort Study

Exclusion Criteria:

  1. Not consenting to participate in the study

  2. 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
  3. Past medical history of angioedema
  4. Medical history of GI bleeding or peptic ulcer in the last 3 months
  5. Pregnancy or lactation
  6. Bleeding disorders such as hemophilia
  7. Receiving regular anticoagulation therapy
  8. Alcohol consumption greater than 40gr/week
  9. Advanced liver disease
  10. Uncontrolled seizures

  11. 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
  12. Past medical history of gout
  13. Serum creatinine values above 2 mg/dL
  14. Glomerular Filtration Rate (GFR) below 30 mL/min
  15. Hemoglobin concentrations below 11 g/dL for males and 10 g/dL for females
  16. BP < 90/60 mmHg
  17. Debilitating medical/mental disorders affecting compliance (including psychosis, disabilities, and blindness)
  18. 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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PolyPill
Single daily dose of PolyPill and minimal care.
Drug: PolyPill
After the baseline enrollment and excluding non-eligible participants, we randomized villages to Polypill and control arms. Follow-ups are scheduled for 1, 3, and 6 months after the initial enrollment in the Polypill arm and every six months thereafter. For the minimal care arm, the follow-ups are arranged every six months.
Other Names:
  • PolyPill-E, Polypill-V
NO_INTERVENTION: Control
Only minimal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Cardiovascular Events (MCVE)
Time Frame: 5 years
the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Non cardiovascular mortality
Time Frame: 5 years
Any death other than those due to CVDs during 5 years
5 years
Level of fasting blood sugar (mg/dL)
Time Frame: 5 years
Changes in fasting blood sugar after 5 years
5 years
Level of blood pressure (mmHg)
Time Frame: 5 years
Changes in blood pressure after 5 years
5 years
Level of total cholesterol (mg/dL)
Time Frame: 5 years
Changes in total cholesterol after 5 years
5 years
Level of HDL (mg/dL)
Time Frame: 5 years
Changes in HDL after 5 years
5 years
Level of LDL (mg/dL)
Time Frame: 5 years
Changes in LDL after 5 years
5 years
Level of triglycerides (mg/dL)
Time Frame: 5 years
Changes in triglycerides after 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

Shiraz University of Medical Sciences

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)

December 20, 2015

Primary Completion (ANTICIPATED)

March 20, 2022

Study Completion (ANTICIPATED)

March 20, 2022

Study Registration Dates

First Submitted

March 3, 2018

First Submitted That Met QC Criteria

March 3, 2018

First Posted (ACTUAL)

March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOH-700/107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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