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Polypill Effects on Sub Clinical Atherosclerosis (PESCA) Trial

NCT01326676 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

DRUG

Polypill: Red Heart Pill

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.

DRUG

Usual medication

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.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Royal College of Surgeons, Ireland

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Simon McG Thom · Imperial College London

  • Alice Stanton · Royal College of Surgeons in Ireland

  • Michiel Bots · UMC Utrecht

  • Alun Hughes · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • Ireland
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01326676 on ClinicalTrials.gov