Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatments polypill, minimal care
Phase phase 3
Sponsor Tehran University of Medical Sciences
Collaborator Golestan University of Medical Science
Start date February 2011
End date April 2018
Trial size 7000 participants
Trial identifier NCT01271985, DDRC.89.17

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
PolyPill once daily and Minimal Care
polypill PolyPill 4-1
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
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
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)
Basic primary health care provided by the local physicians and Community Health Workers consistent with the current Iranian Health Care System guidelines.

Primary Outcomes

Measure
Time to first major cardiovascular event
time frame: 5 years

Secondary Outcomes

Measure
Blood pressure
time frame: 5 years
Fasting blood sugar, total cholesterol, HDL-C and LDL-C
time frame: 5 years
Number of Subjects Developing Adverse Events
time frame: 5 years
Compliance
time frame: 5 years
Rate of major cardiovascular events
time frame: 5 years

Eligibility Criteria

Male or female participants from 50 years up to 79 years old.

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

Additional Information

Official title Fixed-dose Combination Therapy (PolyPill) in Primary and Secondary Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians
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. 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. Comparisons between arm #3 and the other 2 arms are also performed. Endpoints include major cardiovascular events (death and hospitalization)
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.