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

Phase 3CompletedNCT01271985

Tehran University of Medical Sciences8,410 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

8,410

Conditions

Cardiovascular Diseases

Interventions

PolyPillDRUG

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 careOTHER

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Golestan Cohort Study Center

Gonbad, Golestan Province, Iran

Outcomes

Primary Outcomes

Time to first major cardiovascular event

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

Time frame: 5 years

Secondary Outcomes

Blood pressure

Changes in blood pressure after 5 years

Time frame: 5 years

Fasting blood sugar, total cholesterol, HDL-C and LDL-C

Changes in fasting blood sugar and lipid profile after 5 years

Time frame: 5 years

Number of Subjects Developing Adverse Events

Number of participants who experience adverse effects to the PolyPill tablet leading to discontinuation.

Time frame: 5 years

Compliance

Compliance is measured by pill-count in participants of the intervention arm as percent pills taken.

Time frame: 5 years

Rate of major cardiovascular events

Number of major cardiovascular events (as described above) during 5 years

Time frame: 5 years

Data from ClinicalTrials.gov

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