Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease

Summary

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.

Conditions

• Cardiovascular Disease
• Hypertension
• Hyperlipidemia
• Heart Disease

Interventions

DRUG

Polypill

Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily

DRUG

Placebo drug

Inactive tablet Once a day Identical in appearance to intervention drug

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Reza Malekzadeh, M.D. · Tehran University of Medical Sciences

• Fatemeh Malekzadeh, M.D. · Tehran University of Medical Sciences

• Mansoor Rastegarpanah, Ph.D. · Tehran University of Medical Sciences

• Kar K Cheng, PhD · University of Birmingham

• Tom P Marshall, PhD · University of Birmingham

• Akram Pourshams, PhD · Tehran University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2008-06-30

Completion

2008-07-31

Countries

• Iran

Study Locations