02742nas a2200349   4500000000100000008004100001100001700042700001400059700001200073700001500085700002000100700001200120700001300132700001200145700001700157700001300174700001400187700001300201700001400214700001000228700001400238700001700252700001500269700001800284700001600302245023200318250001500550300000800565490000700573520176600580020004602346       2010                            d1 aUsherwood T.1 aCass Alan1 aRing I.1 aStewart G.1 aWeeramanthri T.1 aWade V.1 aBurke H.1 aReid C.1 aTeam Kanyini1 aBrown A.1 aTonkin A.1 aEades S.1 aHayman N.1 aLiu H1 aRodgers A1 aPeiris David1 aNeal Bruce1 aPatel Anushka1 aJan Stephen00aRationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk  a2010/08/07  a4580 v103 a<p>
BACKGROUND: The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. METHODS/DESIGN: The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. DISCUSSION: The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.
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