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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01057537




Registration number
NCT01057537
Ethics application status
Date submitted
26/01/2010
Date registered
27/01/2010
Date last updated
27/11/2012

Titles & IDs
Public title
UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events
Scientific title
A Randomised Controlled Trial of a Fixed-dose Combination Polypill Medication (the Red Heart Pill) and Usual Care in Those at High Risk of Cardiovascular Disease.
Secondary ID [1] 0 0
2009-016278-34
Secondary ID [2] 0 0
241849
Universal Trial Number (UTN)
Trial acronym
UMPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - polypill
Treatment: Drugs - Usual cardiovascular medications

Experimental: polypill - 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.

Active comparator: Usual Care - 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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adherence to medication; self-reported current use of antiplatelet, statin and combination (= 2) blood pressure lowering therapy
Timepoint [1] 0 0
End of trial follow-up
Primary outcome [2] 0 0
Change in blood pressure
Timepoint [2] 0 0
End of trial follow-up
Primary outcome [3] 0 0
Change in LDL cholesterol
Timepoint [3] 0 0
End of trial follow-up
Secondary outcome [1] 0 0
Self reported current use of antiplatelet, statin and combination (>2) blood pressure lowering therapy
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Reasons for stopping cardiovascular medications
Timepoint [2] 0 0
Throughout trial
Secondary outcome [3] 0 0
Serious adverse events
Timepoint [3] 0 0
Throughout trial
Secondary outcome [4] 0 0
New onset cardiovascular events
Timepoint [4] 0 0
Throughout trial
Secondary outcome [5] 0 0
Participant 'Quality of Life' assessment
Timepoint [5] 0 0
At 12 months and end of trial
Secondary outcome [6] 0 0
Changes in total cholesterol and other lipid fractions (HDL-cholesterol, triglycerides)
Timepoint [6] 0 0
12 months and end of trial

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 ßblocker 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
2004
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
George Institute Australia - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Hyderabad
Country [2] 0 0
India
State/province [2] 0 0
New Dehli
Country [3] 0 0
India
State/province [3] 0 0
New Delhi
Country [4] 0 0
Ireland
State/province [4] 0 0
Dublin
Country [5] 0 0
Netherlands
State/province [5] 0 0
Heidelberglaan 100
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Imperial College London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Commission
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Imperial College Healthcare NHS Trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal College of Surgeons, Ireland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
UMC Utrecht
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The George Institute
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Public Health Foundation of India
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Dr. Reddy's Laboratories Limited
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01057537
Trial related presentations / publications
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.
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. Erratum In: JAMA. 2013 Oct 9;310(14):1507. Naik, Nitish [added]; Reddy, Srinivas [added]; Balaji, Sham [corrected to Achuthan, Shyambalaji]; Damodra Rao, Modem [corrected to Damodra Rao, Kodem].
Public notes

Contacts
Principal investigator
Name 0 0
Simon A McG Thom, MD, FRCP
Address 0 0
Imperial College London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01057537