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A Polypill for Secondary Prevention of Ischemic Heart Disease

Primary Purpose

Acute Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Polypill
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Cardiovascular disease, fixed dose combination therapy, cost effectiveness

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chamran cardiology hospitalRecruiting
  • Cardiovascular Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Polypill

Control

Arm Description

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

The usual care arm will receive regular drug order at the time of discharge from the hospital.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

cost-effectiveness of Polypill treatment compared with usual care
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.

Full Information

First Posted
May 17, 2018
Last Updated
October 11, 2020
Sponsor
Isfahan University of Medical Sciences
Collaborators
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03541109
Brief Title
A Polypill for Secondary Prevention of Ischemic Heart Disease
Official Title
Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
Collaborators
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
Keywords
Cardiovascular disease, fixed dose combination therapy, cost effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polypill
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The usual care arm will receive regular drug order at the time of discharge from the hospital.
Intervention Type
Drug
Intervention Name(s)
Polypill
Other Intervention Name(s)
Polypill-S
Intervention Description
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
Primary Outcome Measure Information:
Title
A composite clinical outcome of major adverse cardiovascular events (MACE)
Description
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.
Time Frame
from time of randomization up to 34 months
Secondary Outcome Measure Information:
Title
cost-effectiveness of Polypill treatment compared with usual care
Description
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.
Time Frame
up to 34 months
Other Pre-specified Outcome Measures:
Title
drug related adverse events
Description
assessed by a questionnaire filled by the responsible physician
Time Frame
1 month
Title
drug related adverse events
Description
assessed by a questionnaire filled by the responsible physician
Time Frame
4 months
Title
drug related adverse events
Description
assessed by a questionnaire filled by the responsible physician
Time Frame
10 months
Title
drug related adverse events
Description
assessed by a questionnaire filled by the responsible physician
Time Frame
22 months
Title
drug related adverse events
Description
assessed by a questionnaire filled by the responsible physician
Time Frame
34 months
Title
patient satisfaction with drug consumption
Description
Satisfaction Questionnaire for Medication (TSQM)
Time Frame
1 month
Title
patient satisfaction with drug consumption
Description
Satisfaction Questionnaire for Medication (TSQM)
Time Frame
4 months
Title
patient satisfaction with drug consumption
Description
Satisfaction Questionnaire for Medication (TSQM)
Time Frame
10 months
Title
patient satisfaction with drug consumption
Description
Satisfaction Questionnaire for Medication (TSQM)
Time Frame
22 months
Title
patient satisfaction with drug consumption
Description
Satisfaction Questionnaire for Medication (TSQM)
Time Frame
34 months
Title
health related quality of life
Description
Validated Persian version of the EuroQol-5D (EQ-5D)
Time Frame
1 month
Title
health related quality of life
Description
Validated Persian version of the EuroQol-5D (EQ-5D)
Time Frame
4 months
Title
health related quality of life
Description
Validated Persian version of the EuroQol-5D (EQ-5D)
Time Frame
10 months
Title
health related quality of life
Description
Validated Persian version of the EuroQol-5D (EQ-5D)
Time Frame
22 months
Title
health related quality of life
Description
Validated Persian version of the EuroQol-5D (EQ-5D)
Time Frame
34 months
Title
changes in systolic blood pressure from baseline
Description
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
Time Frame
baseline and 1 month
Title
changes in systolic blood pressure from baseline
Description
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
Time Frame
baseline and 4 months
Title
changes in systolic blood pressure from baseline
Description
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
Time Frame
baseline and 10 months
Title
changes in systolic blood pressure from baseline
Description
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
Time Frame
baseline and 22 months
Title
changes in systolic blood pressure from baseline
Description
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
Time Frame
baseline and 34 months
Title
change in serum LDL from baseline
Description
fasting Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame
baseline and 1 month
Title
change in serum LDL from baseline
Description
fasting Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame
baseline and 4 months
Title
change in serum LDL from baseline
Description
fasting Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame
baseline and 10 months
Title
change in serum LDL from baseline
Description
fasting Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame
baseline and 22 months
Title
change in serum LDL from baseline
Description
fasting Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame
baseline and 34 months
Title
patient adherence to Aspirin at the final visit
Description
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)
Time Frame
34 months
Title
patient adherence to Atorvastatin at the final visit
Description
MMAS-8 questionnaire and pill count
Time Frame
34 months
Title
patient adherence to Metoprolol at the final visit
Description
MMAS-8 questionnaire and pill count
Time Frame
34 months
Title
patient adherence to valsartan at the final visit
Description
MMAS-8 questionnaire and pill count
Time Frame
34 months
Title
patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
Description
MMAS-8 questionnaire and pill count
Time Frame
1 month
Title
patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
Description
MMAS-8 questionnaire and pill count
Time Frame
4 months
Title
patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
Description
MMAS-8 questionnaire and pill count
Time Frame
10 months
Title
patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
Description
MMAS-8 questionnaire and pill count
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masoumeh Sadeghi, Professor
Phone
00989134091776
Email
sadeghimasoumeh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shervin Ghaffari Hoseini, MD,PhD
Email
shghaffari@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoumeh Sadeghi, professor
Organizational Affiliation
Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chamran cardiology hospital
City
Isfahan
ZIP/Postal Code
814651148
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Kelardasht, MS
Phone
00983136115313
Email
Kelardasht@yahoo.com
Facility Name
Cardiovascular Research Institute
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safoora yazdekhasti
Phone
00983136115208
Email
sfa.yazdekhasti@gmail.com
First Name & Middle Initial & Last Name & Degree
Nizal Sarrafzadegan, Professor
First Name & Middle Initial & Last Name & Degree
Shervin Gh Hoseini, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hamidreza Roohafza, MD
First Name & Middle Initial & Last Name & Degree
Marjan Mansourian, PhD
First Name & Middle Initial & Last Name & Degree
Jamshid Najafian, MD
First Name & Middle Initial & Last Name & Degree
Alireza Nateghi Nateghi, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year after study completion
IPD Sharing Access Criteria
Requests will be assessed by a responsible panel after signing a data access agrement.
IPD Sharing URL
http://icri.mui.ac.ir/

Learn more about this trial

A Polypill for Secondary Prevention of Ischemic Heart Disease

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