A Polypill for Secondary Prevention of Ischemic Heart Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| 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 Names:
|
| No Intervention: Control The usual care arm will receive regular drug order at the time of discharge from the hospital. |
Outcome Measures
Primary Outcome Measures
- A composite clinical outcome of major adverse cardiovascular events (MACE) [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
- cost-effectiveness of Polypill treatment compared with usual care [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
- drug related adverse events [1 month]
assessed by a questionnaire filled by the responsible physician
- drug related adverse events [4 months]
assessed by a questionnaire filled by the responsible physician
- drug related adverse events [10 months]
assessed by a questionnaire filled by the responsible physician
- drug related adverse events [22 months]
assessed by a questionnaire filled by the responsible physician
- drug related adverse events [34 months]
assessed by a questionnaire filled by the responsible physician
- patient satisfaction with drug consumption [1 month]
Satisfaction Questionnaire for Medication (TSQM)
- patient satisfaction with drug consumption [4 months]
Satisfaction Questionnaire for Medication (TSQM)
- patient satisfaction with drug consumption [10 months]
Satisfaction Questionnaire for Medication (TSQM)
- patient satisfaction with drug consumption [22 months]
Satisfaction Questionnaire for Medication (TSQM)
- patient satisfaction with drug consumption [34 months]
Satisfaction Questionnaire for Medication (TSQM)
- health related quality of life [1 month]
Validated Persian version of the EuroQol-5D (EQ-5D)
- health related quality of life [4 months]
Validated Persian version of the EuroQol-5D (EQ-5D)
- health related quality of life [10 months]
Validated Persian version of the EuroQol-5D (EQ-5D)
- health related quality of life [22 months]
Validated Persian version of the EuroQol-5D (EQ-5D)
- health related quality of life [34 months]
Validated Persian version of the EuroQol-5D (EQ-5D)
- changes in systolic blood pressure from baseline [baseline and 1 month]
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
- changes in systolic blood pressure from baseline [baseline and 4 months]
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
- changes in systolic blood pressure from baseline [baseline and 10 months]
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
- changes in systolic blood pressure from baseline [baseline and 22 months]
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
- changes in systolic blood pressure from baseline [baseline and 34 months]
average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position
- change in serum LDL from baseline [baseline and 1 month]
fasting Low Density Lipoprotein Cholesterol (LDL-C)
- change in serum LDL from baseline [baseline and 4 months]
fasting Low Density Lipoprotein Cholesterol (LDL-C)
- change in serum LDL from baseline [baseline and 10 months]
fasting Low Density Lipoprotein Cholesterol (LDL-C)
- change in serum LDL from baseline [baseline and 22 months]
fasting Low Density Lipoprotein Cholesterol (LDL-C)
- change in serum LDL from baseline [baseline and 34 months]
fasting Low Density Lipoprotein Cholesterol (LDL-C)
- patient adherence to Aspirin at the final visit [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)
- patient adherence to Atorvastatin at the final visit [34 months]
MMAS-8 questionnaire and pill count
- patient adherence to Metoprolol at the final visit [34 months]
MMAS-8 questionnaire and pill count
- patient adherence to valsartan at the final visit [34 months]
MMAS-8 questionnaire and pill count
- patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [1 month]
MMAS-8 questionnaire and pill count
- patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [4 months]
MMAS-8 questionnaire and pill count
- patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [10 months]
MMAS-8 questionnaire and pill count
- patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan [22 months]
MMAS-8 questionnaire and pill count
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chamran cardiology hospital | Isfahan | Iran, Islamic Republic of | 814651148 | |
| 2 | Cardiovascular Research Institute | Isfahan | Iran, Islamic Republic of |
Sponsors and Collaborators
- Isfahan University of Medical Sciences
- Tehran University of Medical Sciences
Investigators
- Principal Investigator: Masoumeh Sadeghi, professor, Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Persian Polypill