PESCA - A Randomised Controlled Trial of a Cardiovascular Polypill Treatment Strategy Compared With Usual Care on Carotid Intima-media Thickness in Individuals at High Risk of Cardiovascular Disease

Imperial College London3 sites in 3 countriesFebruary 2011

ConditionsCardiovascular Disease

InterventionsUsual medication

DrugsPolypill: Red Heart Pill Usual medication

Overview

Phase: Phase 3
Intervention: Usual medication
Conditions: Cardiovascular Disease
Sponsor: Imperial College London
Locations: 3
Primary Endpoint: change in intima-media (artery wall) thickness in the common carotid artery
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Medications that lower blood pressure and cholesterol are known to improve the shape and function of our blood vessels. These improvements include a reduction in the thickness of the wall of the carotid artery (the main artery that runs up the neck to supply the brain) and a reduction in the stiffness of arteries generally including the main central artery -the aorta. Such medications are in the polypill (the Red Heart Pill) that is being used in the UMPIRE Study. In UMPIRE, patients' reported adherence to taking the single, once daily polypill is being compared to adherence to medications taken as separate tablets (usual care).The aim of the PESCA sub-study is to see whether or not the polypill differs from 'usual care' in its direct effects on blood vessels as shown by ultrasound examination of the carotid arteries and assessment of central (aortic) blood pressure.

Detailed Description

PESCA is a substudy of the UMPIRE clinical trial which is evaluating a 'polypill' treatment strategy for subjects with established cardiovascular disease or at high risk. All PESCA subjects will have already been recruited to UMPIRE and randomised to taking either a single 'polypill' (comprising low dose aspirin, a cholesterol-lowering statin, and one of two blood pressure lowering medicines) or their usual treatment consisting of similar medication in more than one separate tablets. PESCA will evaluate whether: 1) progression of atherosclerosis (fatty deposits which narrow the arteries and impair blood flow to vital organs); and 2) central systolic blood pressure (the pressure in the body's main artery, the aorta, when the heart pumps out blood), are reduced in 'polypill' recipients compared to those who continue their usual treatment. Atherosclerosis and central blood pressure are both strongly associated with increased risk of heart attacks and stroke. Atherosclerosis will be assessed by ultrasound scanning of the carotid (neck) arteries to look at thickness of the artery walls (carotid intima media thickness)and plaques(fatty deposits). Direct measurement of central blood pressure is impractical but it will be estimated using a computerised "pulsecor" device. This uses an inflatable cuff on the arm but provides a detailed recording of the pressure wave as the cuff is deflated which enables "pulsecor" to calculate central blood pressure. Results from both ultrasound and blood pressure investigations will be reviewed by investigators who do not know whether the subjects have been randomised to the polypill or their usual treatment. PESCA assessments will be conducted at 2 visits:baseline (as soon as possible after recruitment to the UMPIRE study); and at the end of both studies (which will coincide). Parallel studies are being undertaken in the three European sites (UK, Eire and Netherlands) participating in the UMPIRE trial with each site aiming to recruit 300 participants.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

September 2012

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel