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A Polypill for Secondary Prevention of Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT03541109
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Masoumeh Sadeghi, Isfahan University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction ST Elevation Myocardial Infarction Non-ST Elevation Myocardial Infarction Drug: Polypill Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Polypill
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
Other Name: Polypill-S
No Intervention: Control
The usual care arm will receive regular drug order at the time of discharge from the hospital.


Outcome Measures
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Primary Outcome Measures :
  1. A composite clinical outcome of major adverse cardiovascular events (MACE) [ Time Frame: from time of randomization up to 34 months ]
    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.


Secondary Outcome Measures :
  1. cost-effectiveness of Polypill treatment compared with usual care [ Time Frame: up to 34 months ]
    The analysis will be done on direct and indirect costs of treatment. Direct costs will be assessed from perspective of health care system. Current Iranian public medical tariffs will be the base of calculations. The incremental cost effectiveness ratio (ICER) will be calculated for primary outcomes.


Other Outcome Measures:
  1. drug related adverse events [ Time Frame: 1 month ]
    assessed by a questionnaire filled by the responsible physician

  2. drug related adverse events [ Time Frame: 4 months ]
    assessed by a questionnaire filled by the responsible physician

  3. drug related adverse events [ Time Frame: 10 months ]
    assessed by a questionnaire filled by the responsible physician

  4. drug related adverse events [ Time Frame: 22 months ]
    assessed by a questionnaire filled by the responsible physician

  5. drug related adverse events [ Time Frame: 34 months ]
    assessed by a questionnaire filled by the responsible physician

  6. patient satisfaction with drug consumption [ Time Frame: 1 month ]
    Satisfaction Questionnaire for Medication (TSQM)

  7. patient satisfaction with drug consumption [ Time Frame: 4 months ]
    Satisfaction Questionnaire for Medication (TSQM)

  8. patient satisfaction with drug consumption [ Time Frame: 10 months ]
    Satisfaction Questionnaire for Medication (TSQM)

  9. patient satisfaction with drug consumption [ Time Frame: 22 months ]
    Satisfaction Questionnaire for Medication (TSQM)

  10. patient satisfaction with drug consumption [ Time Frame: 34 months ]
    Satisfaction Questionnaire for Medication (TSQM)

  11. health related quality of life [ Time Frame: 1 month ]
    Validated Persian version of the EuroQol-5D (EQ-5D)

  12. health related quality of life [ Time Frame: 4 months ]
    Validated Persian version of the EuroQol-5D (EQ-5D)

  13. health related quality of life [ Time Frame: 10 months ]
    Validated Persian version of the EuroQol-5D (EQ-5D)

  14. health related quality of life [ Time Frame: 22 months ]
    Validated Persian version of the EuroQol-5D (EQ-5D)

  15. health related quality of life [ Time Frame: 34 months ]
    Validated Persian version of the EuroQol-5D (EQ-5D)

  16. changes in systolic blood pressure from baseline [ Time Frame: baseline and 1 month ]
    average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position

  17. changes in systolic blood pressure from baseline [ Time Frame: baseline and 4 months ]
    average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position

  18. changes in systolic blood pressure from baseline [ Time Frame: baseline and 10 months ]
    average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position

  19. changes in systolic blood pressure from baseline [ Time Frame: baseline and 22 months ]
    average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position

  20. changes in systolic blood pressure from baseline [ Time Frame: baseline and 34 months ]
    average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position

  21. change in serum LDL from baseline [ Time Frame: baseline and 1 month ]
    fasting Low Density Lipoprotein Cholesterol (LDL-C)

  22. change in serum LDL from baseline [ Time Frame: baseline and 4 months ]
    fasting Low Density Lipoprotein Cholesterol (LDL-C)

  23. change in serum LDL from baseline [ Time Frame: baseline and 10 months ]
    fasting Low Density Lipoprotein Cholesterol (LDL-C)

  24. change in serum LDL from baseline [ Time Frame: baseline and 22 months ]
    fasting Low Density Lipoprotein Cholesterol (LDL-C)

  25. change in serum LDL from baseline [ Time Frame: baseline and 34 months ]
    fasting Low Density Lipoprotein Cholesterol (LDL-C)

  26. patient adherence to Aspirin at the final visit [ Time Frame: 34 months ]
    patient is adherent if achieves a score of more than 6 from validated Persian version of Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8) (score: 0 to 8) and more than 85% of pills prescribed over last 3 months are consumed (pill count method)

  27. patient adherence to Atorvastatin at the final visit [ Time Frame: 34 months ]
    MMAS-8 questionnaire and pill count

  28. patient adherence to Metoprolol at the final visit [ Time Frame: 34 months ]
    MMAS-8 questionnaire and pill count

  29. patient adherence to valsartan at the final visit [ Time Frame: 34 months ]
    MMAS-8 questionnaire and pill count

  30. patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [ Time Frame: 1 month ]
    MMAS-8 questionnaire and pill count

  31. patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [ Time Frame: 4 months ]
    MMAS-8 questionnaire and pill count

  32. patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [ Time Frame: 10 months ]
    MMAS-8 questionnaire and pill count

  33. patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [ Time Frame: 22 months ]
    MMAS-8 questionnaire and pill count


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541109


Contacts
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Contact: Masoumeh Sadeghi, Professor 00989134091776 sadeghimasoumeh@gmail.com
Contact: Shervin Ghaffari Hoseini, MD,PhD shghaffari@yahoo.com

Locations
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Iran, Islamic Republic of
Chamran cardiology hospital Recruiting
Isfahan, Iran, Islamic Republic of, 814651148
Contact: Maryam Kelardasht, MS    00983136115313    Kelardasht@yahoo.com   
Cardiovascular Research Institute Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Safoora yazdekhasti    00983136115208    sfa.yazdekhasti@gmail.com   
Sub-Investigator: Nizal Sarrafzadegan, Professor         
Sub-Investigator: Shervin Gh Hoseini, MD, PhD         
Sub-Investigator: Hamidreza Roohafza, MD         
Sub-Investigator: Marjan Mansourian, PhD         
Sub-Investigator: Jamshid Najafian, MD         
Sub-Investigator: Alireza Nateghi Nateghi, PhD         
Sponsors and Collaborators
Isfahan University of Medical Sciences
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Masoumeh Sadeghi, professor Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
More Information
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Responsible Party: Masoumeh Sadeghi, Head of Cardiac Rehabilitation Research Center, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03541109    
Other Study ID Numbers: Persian Polypill
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://icri.mui.ac.ir/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masoumeh Sadeghi, Isfahan University of Medical Sciences:
Cardiovascular disease
fixed dose combination therapy
cost effectiveness
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases