Prevention of Cardiovascular Disease With Polypill Among Pars Cohort Participants
NCT03459560 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4415
Last updated 2021-02-10
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.
Conditions
Interventions
- DRUG
-
PolyPill
After the baseline enrollment and excluding non-eligible participants, we randomized villages to Polypill and control arms. Follow-ups are scheduled for 1, 3, and 6 months after the initial enrollment in the Polypill arm and every six months thereafter. For the minimal care arm, the follow-ups are arranged every six months.
Sponsors & Collaborators
-
Shiraz University of Medical Sciences
collaborator OTHER -
Tehran University of Medical Sciences
lead OTHER
Principal Investigators
-
Reza Malekzadeh, MD · Tehran University of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-20
- Primary Completion
- 2022-03-20
- Completion
- 2022-03-20
Countries
- Iran
Study Locations
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