A Polypill for Secondary Prevention of Ischemic Heart Disease
Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
1 other identifier
interventional
1,200
1 country
2
Brief Summary
Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2019
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedOctober 14, 2020
October 1, 2020
4.2 years
May 17, 2018
October 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite clinical outcome of major adverse cardiovascular events (MACE)
MACE includes cardiac death, fatal/nonfatal MI or stroke, hospitalization due to acute coronary syndrome/acute cerebrovascular accident, revascularization procedures, development or worsening of HF, and development of persistent new AF.
from time of randomization up to 34 months
Secondary Outcomes (1)
cost-effectiveness of Polypill treatment compared with usual care
up to 34 months
Other Outcomes (33)
drug related adverse events
1 month
drug related adverse events
4 months
drug related adverse events
10 months
- +30 more other outcomes
Study Arms (2)
Polypill
EXPERIMENTALPolypill 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
Control
NO INTERVENTIONThe usual care arm will receive regular drug order at the time of discharge from the hospital.
Interventions
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
Eligibility Criteria
You may qualify if:
- Patients hospitalized because of an acute myocardial infarction (STEMI/NSTEMI) and alive after discharge for at least 1 month
- 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
You may not qualify if:
- Patient unlikely to complete trial
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chamran cardiology hospital
Isfahan, 814651148, Iran
Cardiovascular Research Institute
Isfahan, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masoumeh Sadeghi, professor
Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiac Rehabilitation Research Center
Study Record Dates
First Submitted
May 17, 2018
First Posted
May 30, 2018
Study Start
May 20, 2019
Primary Completion
August 1, 2023
Study Completion
August 1, 2024
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 1 year after study completion
- Access Criteria
- Requests will be assessed by a responsible panel after signing a data access agrement.