Prevention of Cardiovascular Disease With Polypill Among Pars Cohort Participants

• Status: Active, not recruiting
• Trial end date: 2022-03-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborator: Shiraz University of Medical Sciences
• Treatments: Aspirin

Criteria

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