Hypertension Clinical Trial
Official title:
Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy
Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In
Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are
consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths
attributed to cardiovascular events. Cardiovascular diseases will become an increasing
problem as the Iranian population ages.
In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose
combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a
single preparation. They proposed that this treatment should be offered to all persons at
high risk of cardiovascular disease whether or not they have elevated blood pressure or
elevated serum lipid concentrations.
This pilot study aims to investigate the safety and efficacy of fixed-dose combination
therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would
not currently be considered eligible for antihypertensive treatment or for lipid lowering
treatment.
Methods:
This is a double-blind randomized controlled trial. The intervention group will be assigned
to take a tablet consisting of a single daily tablet comprising Aspirin 81mg,
Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be
assigned to an identical placebo.
The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80
(inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering
therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total
cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore
lipid lowering therapy are excluded.
It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome
for the purpose of sample size calculation is change in systolic blood pressure. Additional
outcomes include change in diastolic blood pressure, change in LDL cholesterol and
occurrence of adverse events.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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