UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events

Summary

People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity \& cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.

Conditions

• Cardiovascular Diseases

Interventions

DRUG

polypill

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.

DRUG

Usual cardiovascular medications

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

• European Commission

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Royal College of Surgeons, Ireland

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• The George Institute

  collaborator OTHER

• Public Health Foundation of India

  collaborator OTHER

• Dr. Reddy's Laboratories Limited

  collaborator INDUSTRY

• Imperial College London

  lead OTHER

Principal Investigators

• Simon A McG Thom, MD, FRCP · Imperial College London

• Neil Poulter · Imperial College London

• Anushka Patel · The George Institute, India

• Dorairaj Prabhakaran · Centre for Chronic Disease Control

• Michiel Bots · UMC Utrecht

• Diederick Grobbee · UMC Utrecht

• Alice Stanton · Royal College of Surgeons in Ireland

• Anthony Rodgers · The George Institute, Australia

• Raghu Cidambi · Dr. Reddy's Laboratories Limited

• K Srinath Reddy · Public Health Foundation of India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2012-07-31

Completion

2012-09-30

Countries

• Australia
• India
• Ireland
• Netherlands
• United Kingdom

Study Locations