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

Phase 2

Completed

• Conditions: Cardiovascular Disease; Hypertension; Hyperlipidemia; Heart Disease
• Interventions: Drug: Polypill; Drug: Placebo drug

• Registration Number: NCT00603590
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-01-01
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Results First Submitted: 2009-04-13
• Results First Submitted QC: 2009-05-02
• Results First Posted: 2009-06-23
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-22
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polypill	Polypill	Fixed dose combination therapy with Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg
Control	Placebo drug	Identical placebo

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	One year	Systolic blood pressure. Mean of two seated measurements.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	One year	Mean of two seated diastolic blood pressures
LDL Cholesterol	One year	Serum LDL cholesterol

Trial Locations

Locations (1)

Kalaleh Heart Study Center; 🇮🇷 Kalaleh, Golestan, Iran, Islamic Republic of