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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Golestan University of Medical Science
University of Birmingham
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01271985
First received: December 14, 2010
Last updated: October 21, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
 Drug: PolyPill
Other: Minimal care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Fixed-dose Combination Therapy (PolyPill) in Primary and Secondary Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Time to first major cardiovascular event [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Changes in blood pressure after 5 years

  • Fasting blood sugar, total cholesterol, HDL-C and LDL-C [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Changes in fasting blood sugar and lipid profile after 5 years

  • Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Number of participants who experience adverse effects to the PolyPill tablet,

  • Compliance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Compliance is measured by pill-count in participants of the intervention arm

  • Rate of major cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Number of major cardiovascular events (as described above) during 5 years


Estimated Enrollment: 7000
Study Start Date: February 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.

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 cmRCT. The study comprises three arms as follows:

  1. 3500 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. 3500 randomly selected participants receive only Minimal care as described above.
  3. 24000 participants receive usual care (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).

Arms #1 and #2 are compared via a 2-armed open-labeled cluster Randomized Controlled Trial. The comparisons between arm #3 and the other 2 arms are performed by means of a cohort multiple Randomized Controlled Trial (cmRCT) design.

Endpoints include major cardiovascular events (death and hospitalization)

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271985

Locations
Iran, Islamic Republic of
Golestan Cohort Study 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. Digestive Disease Research Center
  More Information

Publications:

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01271985     History of Changes
Other Study ID Numbers: DDRC.89.17
Study First Received: December 14, 2010
Last Updated: October 21, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Cardiovascular Diseases
Drug Combinations
prevention and control
 Aspirin
Antihypertensive Agents
Antilipemic Agents

Additional relevant MeSH terms:
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013