A Phase 3 interventional study of PolyPill in Cardiovascular Diseases, sponsored by Tehran University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Tehran University of Medical Sciences · Phase 3, Interventional, and Prevention
The purpose of this study is to determine the effects of a fixed dose combination of enalapril (or valsartan), with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in participants of Pars Cohort of Iran.
Cardiovascular diseases (CVDs) are the most common causes of death and disability in Iran and account for nearly half of all-cause mortality in Iranians. Therefore, prevention of cardiovascular diseases is a top priority in countries with limited health system budgets such as Iran.
Eighty seven to hundred percent of patients dying from CVDs have at least one risk factor for cardiovascular diseases. Therefore, risk factor modification might prevent death and is a main priority. Combination drug therapy has been proposed as a cost-effective measure to reduce modifiable risk factors for cardiovascular disease. It has been showed that combination drug therapy can potentially decrease ischemic heart events and strokes by 88 and 80 percent, respectively.
The study is designed as a pragmatic cluster randomized controlled trial. The purpose of this study is to determine the effects of a fixed dose combination of either enalapril or valsartan, with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50. Two formulations of Polypill tablets were used. The first formulation (Polypill-E) contained enalapril 5 mg. If participants developed cough, they were switched by a trained physician to Polypill-V, containing valsartan 40 mg instead of enalapril.
The investigators have previously tested the same combination in a different setting in Golestan, Northeast of Iran. The results of the study were published in the Lancet. The current study enrolls participants of Pars Cohort running in Fars province, southern Iran, aged above 50. A total of 4415 participants (91 clusters) were recruited following inclusion and exclusion criteria. The study comprises two arms as follows:
2200 randomly selected participants receive PolyPill tablets once daily and minimal care (which consists of direct education and pamphlet on cardiovascular risk reduction).
2215 randomly selected participants receive only minimal care as described above.
Endpoints include major cardiovascular events (MCVE).
Exclusion Criteria:
Hypersensitivity to any of PolyPill components:
Asthma with any of the following criteria present:
Single daily dose of PolyPill and minimal care.
Drug: PolyPill
Only minimal care
After the baseline enrollment and excluding non-eligible participants, we randomized villages to Polypill and control arms. Follow-ups are scheduled for 1, 3, and 6 months after the initial enrollment in the Polypill arm and every six months thereafter. For the minimal care arm, the follow-ups are arranged every six months.
Also known as: PolyPill-E, Polypill-V
Major Cardiovascular Events (MCVE)
the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions.
Time frame: 5 years
Number of Subjects Developing Adverse Events
Number of participants who experience adverse effects to the PolyPill tablet leading to discontinuation
Time frame: 5 years
Compliance
Compliance is measured by pill-count in participants of the intervention arm as percent pills taken
Time frame: 5 years
Non cardiovascular mortality
Any death other than those due to CVDs during 5 years
Time frame: 5 years
Level of fasting blood sugar (mg/dL)
Changes in fasting blood sugar after 5 years
Time frame: 5 years
Level of blood pressure (mmHg)
Changes in blood pressure after 5 years
Time frame: 5 years
Level of total cholesterol (mg/dL)
Changes in total cholesterol after 5 years
Time frame: 5 years
Level of HDL (mg/dL)
Changes in HDL after 5 years
Time frame: 5 years
Level of LDL (mg/dL)
Changes in LDL after 5 years
Time frame: 5 years
Level of triglycerides (mg/dL)
Changes in triglycerides after 5 years
Time frame: 5 years
Plan to share: No
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Tehran University of Medical Sciences