Polypill Effects on Sub Clinical Atherosclerosis (PESCA) Trial

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare NHS Trust; Royal College of Surgeons, Ireland; UMC Utrecht

Criteria

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 pregnant or breastfeeding women during the treatment period).

• The treating doctor considers that changing a participant's cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose β-blocker required to manage angina or for rate control in atrial fibrillation, accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension).

Other potential reasons for exclusion include:

• Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation.

• Unlikely to complete the trial (e.g. life-threatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).