Clinical trial NCT03541109: A Polypill for Secondary Prevention of Ischemic Heart Disease
Official title: Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myocardial Infarction
ST Elevation Myocardial Infarction
Non-ST Elevation Myocardial Infarction
Keywords: Cardiovascular disease
fixed dose combination therapy
cost effectiveness
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
First posted: 2018-05-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: A composite clinical outcome of major adverse cardiovascular events (MACE)
timeFrame: from time of randomization up to 34 months
Secondary outcomes:
measure: cost-effectiveness of Polypill treatment compared with usual care
timeFrame: up to 34 months
Other outcomes:
measure: drug related adverse events
timeFrame: 1 month
measure: drug related adverse events
timeFrame: 4 months
measure: drug related adverse events
timeFrame: 10 months
measure: drug related adverse events
timeFrame: 22 months
measure: drug related adverse events
timeFrame: 34 months
measure: patient satisfaction with drug consumption
timeFrame: 1 month
measure: patient satisfaction with drug consumption
timeFrame: 4 months
measure: patient satisfaction with drug consumption
timeFrame: 10 months
measure: patient satisfaction with drug consumption
timeFrame: 22 months
measure: patient satisfaction with drug consumption
timeFrame: 34 months
measure: health related quality of life
timeFrame: 1 month
measure: health related quality of life
timeFrame: 4 months
measure: health related quality of life
timeFrame: 10 months
measure: health related quality of life
timeFrame: 22 months
measure: health related quality of life
timeFrame: 34 months
measure: changes in systolic blood pressure from baseline
timeFrame: baseline and 1 month
measure: changes in systolic blood pressure from baseline
timeFrame: baseline and 4 months
measure: changes in systolic blood pressure from baseline
timeFrame: baseline and 10 months
measure: changes in systolic blood pressure from baseline
timeFrame: baseline and 22 months
measure: changes in systolic blood pressure from baseline
timeFrame: baseline and 34 months
measure: change in serum LDL from baseline
timeFrame: baseline and 1 month
measure: change in serum LDL from baseline
timeFrame: baseline and 4 months
measure: change in serum LDL from baseline
timeFrame: baseline and 10 months
measure: change in serum LDL from baseline
timeFrame: baseline and 22 months
measure: change in serum LDL from baseline
timeFrame: baseline and 34 months
measure: patient adherence to Aspirin at the final visit
timeFrame: 34 months
measure: patient adherence to Atorvastatin at the final visit
timeFrame: 34 months
measure: patient adherence to Metoprolol at the final visit
timeFrame: 34 months
measure: patient adherence to valsartan at the final visit
timeFrame: 34 months
measure: patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
timeFrame: 1 month
measure: patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
timeFrame: 4 months
measure: patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
timeFrame: 10 months
measure: patient adherence to Aspirin, Atorvastatin, Metoprolol, Valsartan
timeFrame: 22 months
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Chamran cardiology hospital
city: Isfahan
country: Iran, Islamic Republic of
facility: Cardiovascular Research Institute
Study officials:
affiliation: Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
name: Masoumeh Sadeghi, professor
role: PRINCIPAL_INVESTIGATOR
References: