A Polypill for Secondary Prevention of Ischemic Heart Disease
NCT ID: NCT03541109
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1200 participants
INTERVENTIONAL
2019-05-20
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Polypill
Polypill group will receive a fixed dose combinations of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg), prescribed once daily by moth for 34 months
Polypill
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
Control
The usual care arm will receive regular drug order at the time of discharge from the hospital.
No interventions assigned to this group
Interventions
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Polypill
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* signing informed consent
* clear indication of receiving all components of Polypill (aspirin, statin, ACE inhibitor/ARB, and beta blocker)
* living in Isfahan city or nearby areas so that they can attend follow-ups
* No mental illness limiting their self-care ability or Severe illness with an estimated lifespan of less than 3 years
* No history of adverse reaction or contraindication to any component of the Polypill
* Not having Secondary hyperlipidemia, serum creatinine ≥ 2, severe heart failure
* No plan for a procedure (CABG, PCI, or another surgical procedures) within following 6 months
Exclusion Criteria
* Need to change or discontinue any of the four principal drugs of the Polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea)
* Severe illness with an estimated lifespan of less than 3 years
40 Years
80 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Isfahan University of Medical Sciences
OTHER
Responsible Party
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Masoumeh Sadeghi
Head of Cardiac Rehabilitation Research Center
Principal Investigators
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Masoumeh Sadeghi, professor
Role: PRINCIPAL_INVESTIGATOR
Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Locations
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Chamran cardiology hospital
Isfahan, , Iran
Cardiovascular Research Institute
Isfahan, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Persian Polypill
Identifier Type: -
Identifier Source: org_study_id
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