Status:
UNKNOWN
Prevention of Cardiovascular Disease With Polypill Among Pars Cohort Participants
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Shiraz University of Medical Sciences
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
50-79 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Cardiovascular diseases (CVDs) are the most common causes of death and disability in Iran and account for nearly half of all-cause mortality in Iranians. Therefore, prevention of cardiovascular diseas...
Eligibility Criteria
Inclusion
- 50-79 years old
- Enrollment in the Pars Cohort Study
Exclusion
- Not consenting to participate in the study
- Hypersensitivity to any of PolyPill components:
- Hypersensitivity to Non-steroidal anti-inflammatory agents
- Hypersensitivity to statins
- Hypersensitivity to hydrochlorothiazide or sulfonamides
- Hypersensitivity to enalapril and valsartan
- Past medical history of angioedema
- Medical history of GI bleeding or peptic ulcer in the last 3 months
- Pregnancy or lactation
- Bleeding disorders such as hemophilia
- Receiving regular anticoagulation therapy
- Alcohol consumption greater than 40gr/week
- Advanced liver disease
- Uncontrolled seizures
- Asthma with any of the following criteria present:
- Daily symptoms
- Asthmatic attacks waking the patient from sleep more than once a week
- History of nasal polyps
- Aspirin sensitive asthma
- Presence of rhinitis symptoms not due to infection
- Past medical history of gout
- Serum creatinine values above 2 mg/dL
- Glomerular Filtration Rate (GFR) below 30 mL/min
- Hemoglobin concentrations below 11 g/dL for males and 10 g/dL for females
- BP \< 90/60 mmHg
- Debilitating medical/mental disorders affecting compliance (including psychosis, disabilities, and blindness)
- Past medical history of stroke
Key Trial Info
Start Date :
December 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2022
Estimated Enrollment :
4415 Patients enrolled
Trial Details
Trial ID
NCT03459560
Start Date
December 20 2015
End Date
March 20 2022
Last Update
February 10 2021
Active Locations (1)
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1
Pars Cohort Center
Shiraz, Fars, Iran