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TIPS, 2009 - polypill vs error

UMPIRE study,
[NCT01057537] Ongoing trial	download pdf: polypill | polypill for cardiovascular prevention

Treatments

Studied treatment

fixed-dose, once-daily combination polypill, the Red Heart Pill 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. 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

Control treatment

Usual cardiovascular medications

Patients

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

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 �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. lifethreatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).

Method and design

Randomized effectives	NA / NA (studied vs. control)
Design	Parallel groups
Blinding	Open
Primary endpoint	�Adherence to medication

Results

No results available for this trial - ongoing study

Meta-analysis of all similar trials:

polypill in cardiovascular prevention for all type of patients

Reference(s)

Trials register #

NCT01057537