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

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborators: Golestan University of Medical Science; University of Birmingham

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