Polypill Effects on Sub Clinical Atherosclerosis (PESCA) Trial

NCT01326676 | Withdrawn Phase 3 DMC

• 1 other identifier: CRO1656 (Sub-study of 241849 )
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 3

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.

Conditions

Cardiovascular Disease

Keywords

Polypill; Red Heart Pill; Cardiovascular disease; Secondary prevention; carotid intima media thickness

Outcome Measures

Primary Outcomes (3)

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

  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

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

• change in central aortic blood pressure

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

Study Arms (2)

polypill

EXPERIMENTAL

Red Heart Pill Version 1 and Red Heart Pill Version 2.

Drug: Polypill: Red Heart Pill

usual medication

ACTIVE COMPARATOR

participants continuing to receive cardiovascular disease medications as separate tablets prescribed by their usual physician

Drug: Usual medication

Interventions

Polypill: Red Heart Pill DRUG

The polypill will be taken once/day in the form of a hard capsule, to be taken orally. There are two versions of the polypill (Red Heart Pill): Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg. Red Heart Pill Version 1 and Red Heart Pill Version 2. In general, participants with a history of coronary heart disease will be given version 1, and those with a history of stroke or cerebrovascular disease will be given version 2.

polypill

Usual medication DRUG

Participants in the 'Usual Care' arm will continue to take the separate, individual medications prescribed by their usual doctor, e.g. aspirin, blood pressure lowering drugs, statins.

Also known as: Usual cardiovascular disease prevention medication

usual medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Royal College of Surgeons, Ireland: collaborator
• UMC Utrecht: collaborator

Study Sites (3)

Royal College of Surgeons of Ireland Research Institute

Dublin, Ireland

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Imperial College London

London, W2 1LA, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Simon McG Thom

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Alice Stanton

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

• Michiel Bots

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Alun Hughes

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 31, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

GB (1); IE (1); NL (1)