Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease
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.
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.
Drug: Placebo drug
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy|
- Systolic Blood Pressure [ Time Frame: One year ] [ Designated as safety issue: No ]
- Diastolic Blood Pressure [ Time Frame: One year ] [ Designated as safety issue: No ]
- LDL Cholesterol [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Fixed dose combination therapy with Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg
Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily
Placebo Comparator: Control
Drug: Placebo drug
Inactive tablet Once a day Identical in appearance to intervention drug
|Iran, Islamic Republic of|
|Kalaleh Heart Study Center|
|Kalaleh, Golestan, Iran, Islamic Republic of|
|Study Chair:||Reza Malekzadeh, M.D.||Tehran University of Medical Sciences|
|Principal Investigator:||Fatemeh Malekzadeh, M.D.||Tehran University of Medical Sciences|
|Principal Investigator:||Mansoor Rastegarpanah, Ph.D.||Tehran University of Medical Sciences|
|Study Chair:||Kar K Cheng, PhD||University of Birmingham|
|Principal Investigator:||Tom P Marshall, PhD||University of Birmingham|
|Study Director:||Akram Pourshams, PhD||Tehran University of Medical Sciences|