UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events

NCT01057537 | Completed Phase 3 DMC

• 2 other identifiers: 2418492009-016278-34
• Study Type: interventional
• Target: 2,004
• Locations: 5 countries
• Sites: 7

Brief 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

Keywords

Polypill; Red Heart Pill; Cardiovascular disease; Adherence; Secondary prevention

Outcome Measures

Primary Outcomes (3)

• Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy

  End of trial follow-up

• Change in blood pressure

  End of trial follow-up

• Change in LDL cholesterol

  End of trial follow-up

Secondary Outcomes (6)

• Self reported current use of antiplatelet, statin and combination (>2) blood pressure lowering therapy

  12 months

• Reasons for stopping cardiovascular medications

  Throughout trial

• Serious adverse events

  Throughout trial

• New onset cardiovascular events

  Throughout trial

• Participant 'Quality of Life' assessment

  At 12 months and end of trial

Study Arms (2)

polypill

EXPERIMENTAL

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: polypill

Usual Care

ACTIVE COMPARATOR

Participants in the usual care arm will take their usual cardiovascular medications. The participants will be seen as needed by their usual doctor between study visits.

Drug: Usual cardiovascular medications

Interventions

polypill 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.

Also known as: Red Heart Pill

polypill

Usual cardiovascular medications 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 Care

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, of 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
• The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better.

You may not qualify if:

• 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 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 βblocker 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. lifethreatening 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
• European Commission: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Royal College of Surgeons, Ireland: collaborator
• UMC Utrecht: collaborator
• The George Institute: collaborator
• Public Health Foundation of India: collaborator
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (7)

George Institute Australia

Sydney, New South Wales, 2050, Australia

Location

George Institute for International Health - India

Hyderabad, 500033, India

Location

Public Health Foundation of India

New Dehli, 110049, India

Location

Centre for Chronic Disease Control

New Delhi, 110016, India

Location

Royal College of Surgeons in Ireland Research Institute

Dublin, Dublin 9, Ireland

Location

University Medical Center Utrecht

Utrecht, Heidelberglaan 100, 3584 CX, Netherlands

Location

Clinical Investigation Unit, International Centre for Circulatory Health, Imperial College London

Paddington, London, W2 1LA, United Kingdom

Location

Related Publications (2)

• Thom S, Field J, Poulter N, Patel A, Prabhakaran D, Stanton A, Grobbee DE, Bots ML, Reddy KS, Cidambi R, Rodgers A. Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE): rationale and design of a randomised controlled trial of a cardiovascular preventive polypill-based strategy in India and Europe. Eur J Prev Cardiol. 2014 Feb;21(2):252-61. doi: 10.1177/2047487312463278. Epub 2012 Oct 4.

  PMID: 23038750 BACKGROUND

• Thom S, Poulter N, Field J, Patel A, Prabhakaran D, Stanton A, Grobbee DE, Bots ML, Reddy KS, Cidambi R, Bompoint S, Billot L, Rodgers A; UMPIRE Collaborative Group. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA. 2013 Sep 4;310(9):918-29. doi: 10.1001/jama.2013.277064.

  PMID: 24002278 DERIVED

Related Links

• Single Pill to Avert Cardiovascular Events (SPACE) website for multinational polypill (RHP) trials

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Simon A McG Thom, MD, FRCP

  Imperial College London

  STUDY DIRECTOR

• Neil Poulter

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Anushka Patel

  The George Institute, India

  PRINCIPAL INVESTIGATOR

• Dorairaj Prabhakaran

  Centre for Chronic Disease Control

  PRINCIPAL INVESTIGATOR

• Michiel Bots

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Diederick Grobbee

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Alice Stanton

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

• Anthony Rodgers

  The George Institute, Australia

  PRINCIPAL INVESTIGATOR

• Raghu Cidambi

  Dr. Reddy's Laboratories Limited

  PRINCIPAL INVESTIGATOR

• K Srinath Reddy

  Public Health Foundation of India

  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: January 26, 2010
• First Posted: January 27, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

NL (1); IN (3); IE (1); AU (1); GB (1)