A Polypill for Secondary Prevention of Ischemic Heart Disease

Acute Myocardial Infarction Clinical Trial

Official title:

Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03541109
• Other study ID #: Persian Polypill
• Status: Recruiting
• Phase: Phase 3
• Start date: May 20, 2019
• Est. completion date: August 2024

Study information

• Verified date: October 2020
• Source: Isfahan University of Medical Sciences
• Contact: Masoumeh Sadeghi, Professor
• Phone: 00989134091776
• Email: sadeghimasoumeh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Polypill
fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Cardiovascular Research Institute	Isfahan
Iran, Islamic Republic of	Chamran cardiology hospital	Isfahan

Sponsors (2)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	drug related adverse events	assessed by a questionnaire filled by the responsible physician	1 month
Other	drug related adverse events	assessed by a questionnaire filled by the responsible physician	4 months
Other	drug related adverse events	assessed by a questionnaire filled by the responsible physician	10 months
Other	drug related adverse events	assessed by a questionnaire filled by the responsible physician	22 months
Other	drug related adverse events	assessed by a questionnaire filled by the responsible physician	34 months
Other	patient satisfaction with drug consumption	Satisfaction Questionnaire for Medication (TSQM)	1 month
Other	patient satisfaction with drug consumption	Satisfaction Questionnaire for Medication (TSQM)	4 months
Other	patient satisfaction with drug consumption	Satisfaction Questionnaire for Medication (TSQM)	10 months
Other	patient satisfaction with drug consumption	Satisfaction Questionnaire for Medication (TSQM)	22 months
Other	patient satisfaction with drug consumption	Satisfaction Questionnaire for Medication (TSQM)	34 months
Other	health related quality of life	Validated Persian version of the EuroQol-5D (EQ-5D)	1 month
Other	health related quality of life	Validated Persian version of the EuroQol-5D (EQ-5D)	4 months
Other	health related quality of life	Validated Persian version of the EuroQol-5D (EQ-5D)	10 months
Other	health related quality of life	Validated Persian version of the EuroQol-5D (EQ-5D)	22 months
Other	health related quality of life	Validated Persian version of the EuroQol-5D (EQ-5D)	34 months
Other	changes in systolic blood pressure from baseline	average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position	baseline and 1 month
Other	changes in systolic blood pressure from baseline	average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position	baseline and 4 months
Other	changes in systolic blood pressure from baseline	average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position	baseline and 10 months
Other	changes in systolic blood pressure from baseline	average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position	baseline and 22 months
Other	changes in systolic blood pressure from baseline	average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position	baseline and 34 months
Other	change in serum LDL from baseline	fasting Low Density Lipoprotein Cholesterol (LDL-C)	baseline and 1 month
Other	change in serum LDL from baseline	fasting Low Density Lipoprotein Cholesterol (LDL-C)	baseline and 4 months
Other	change in serum LDL from baseline	fasting Low Density Lipoprotein Cholesterol (LDL-C)	baseline and 10 months
Other	change in serum LDL from baseline	fasting Low Density Lipoprotein Cholesterol (LDL-C)	baseline and 22 months
Other	change in serum LDL from baseline	fasting Low Density Lipoprotein Cholesterol (LDL-C)	baseline and 34 months
Other	patient adherence to Aspirin at the final visit	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)	34 months
Other	patient adherence to Atorvastatin at the final visit	MMAS-8 questionnaire and pill count	34 months
Other	patient adherence to Metoprolol at the final visit	MMAS-8 questionnaire and pill count	34 months
Other	patient adherence to valsartan at the final visit	MMAS-8 questionnaire and pill count	34 months
Other	patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan	MMAS-8 questionnaire and pill count	1 month
Other	patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan	MMAS-8 questionnaire and pill count	4 months
Other	patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan	MMAS-8 questionnaire and pill count	10 months
Other	patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan	MMAS-8 questionnaire and pill count	22 months
Primary	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	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.	up to 34 months