Guidelines Adherence to the Polypill Study. A clinical trial of a fixed dose combination medication (Polypill) versus usual care for improved adherence to indicated pharmacotherapy among individuals at high risk of a cardiovascular event.
- Conditions
- Cardiovascular diseaseCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12608000584336
- Lead Sponsor
- The George Institute for International Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 1000
1.Adults aged 18 years and over
2.High cardiovascular risk defined by: History of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease), or Calculated 5 year Cardiovascular Disease (CVD) risk of 15% or greater. Five year CVD risk will be calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations
3.The responsible clinician believes that each of the polypill components are indicated and can be prescribed under the Pharmaceuticals Benefit Scheme
4.The responsible clinician is unsure as to whether a polypill-based strategy or usual care is better
5.participant is able to give informed consent
- Contraindication to any components of the polypill - 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 18 months)];Change in blood pressure from baseline to the end of follow-up, measured by sphygmomanometer[Baseline visit, 12month visit, end of study visit];Change in total cholesterol from baseline to the end of follow-up (average 18 months) as determined by blood analysis[Baseline visit, 12 month visit, end of study visit (average 18 months)]
- Secondary Outcome Measures
Name Time Method