WithdrawnPhase 3

Polypill Effects on Sub Clinical Atherosclerosis (PESCA) Trial

Stopped: Funding never attained

Ireland, Netherlands, United Kingdom0Started 2011-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients must meet the inclusion criteria for the UMPIRE trial, and be consented to take part in the PESCA sub-study. Inclusion criteria Individuals are eligible for inclusion if all of the following criteria are satisfied: Adults (≥ 18 years) The participant is able to give informed consent. Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, defined as; * History of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or * History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or * History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease), or * For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations) The trial Investigator considers that each of the polypill components are indicated at the doses in the Red Heart Pill The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better. Exclusion criteria Individuals will NOT be eligible if one or more of the following criteria are satisfied: * Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors; pregnancy or likely to become pregn…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in intima-media (artery wall) thickness in the common carotid artery

Timeframe: from baseline to end of trial follow up (1-2 years)

change in intima-media (artery wall) thickness and extent of atherosclerotic plaques in the carotid artery bifurcation

Timeframe: from baseline to end of trial follow-up (1-2 years)

change in central aortic blood pressure

Timeframe: from baseline to end of trial follow-up (1-2 years)

Trial details

NCT IDNCT01326676

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

View on ClinicalTrials.gov More Cardiovascular Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

change in intima-media (artery wall) thickness in the common carotid artery

Timeframe: from baseline to end of trial follow up (1-2 years)

change in intima-media (artery wall) thickness and extent of atherosclerotic plaques in the carotid artery bifurcation

Timeframe: from baseline to end of trial follow-up (1-2 years)

change in central aortic blood pressure

Timeframe: from baseline to end of trial follow-up (1-2 years)