UMPIRE, polypill versus usual care

Ongoing trial

NCT01057537    

polypill versus usual care in




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
Group sizes -9 / -9
Inclusion criteriaadults (>= 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 criteriacontraindication 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).



Blindness Open Inclusion period Jun 2010 -
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint •Adherence to medication Design Parallel groups



EndpointX1N1X0N0TE95% CI0,22,01,0


 




Appears in following systematic reviews: