The Kanyini Guidelines Adherence with the Polypill Study- A clinical trial to investigate whether a fixed dose combination 'Polypill' Medication is better than existing treatments for people at high risk of cardiovascular disease.

Phase 3

Completed

• Conditions: Cardiovascular disease; High Risk Cardiovascular Disease; Medication Adherence; Cardiovascular - Other cardiovascular diseases; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12608000583347
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Adults aged 18 years and older, 2. Participant is able to give informed consent, 3. High cardiovascular risk defined by: history of coronary heart disease, history of ischaemic cerebrovascular disease, history of peripheral vascular disease or calculated 5 year cardiovascular disease (CVD) risk or greater using the 1991 Anderson Framingham risk equation with adjustments as defined by the National Heart Foundation (NHF) Hypertension guidelines. 4. The responsible clinician believes each of the polypill components are indicated and can be prescribed under the Pharmaceutical Benefits Scheme (PBS), 5.The responsible clinician is unsure as to whether a polypill based strategy or usual care is better. 6. Additionally, Aboriginal and/or Torres Strait Islander participants should have their status recorded by the participating health service and confirmed by self-identification.

Exclusion Criteria

1. Contraindication to any components of the polypill, 2. the responsible clinician feels change to current therapy will place a patient at risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence: Self-reported current use of antiplatelet, statin, and combination (2 or more) blood pressure lowering therapy[end of study (average 12 months) ];Change in blood pressure from baseline to the end of follow-up, measured by sphygmomanometer[Baseline visit, 12month visit, end of study visit (average 12 months) ];Change in total cholesterol from baseline to the end of follow-up as determined by blood analysis[Baseline visit, 12 month visit, end of study visit (average 18 months) ]