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.

A randomised controlled trial of a fixed dose combination medication (Polypill) versus usual care for improved adherence to indicated pharmacotherapy among Indigenous and Non-Indigenous people at high risk of a cardiovascular event.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000583347

Acronym

Kanyini GAP

Enrollment

1000

Registered

2008-11-21

Start date

2009-10-31

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Kanyini Guidelines Adherence with the Polypill study is a research study which looks to compare a combination heart medicine called the "polypill" with existing treatments. The polypill has 4 different types of medicine in the one tablet. It contains aspirin, a cholesterol lowering medicine and two blood pressure lowering medicines. All four medicines have been available in Australia for a long time and are known to be very safe; the only difference is that they have been put into one tablet rather than four separate tablets. We think that this will make it easier for clients to take their medicine every day. We also think that by making these medicines easier to take it will be better at lowering blood pressure and cholesterol levels than taking many different tablets. This has not been proven and that is why we are conducting this important research to see if this is true.

Interventions

Polypill - 2 versions containing: Version 1c - atenolol 50mg, aspirin 75mg, simvastatin 40mg, lisinopril 10mg Details: one tablet taken orally per day for an average of 12 months. Version 2c - hydrochlorothiazide 12.5mg, aspirin 75mg, simvastatin 40mg, lisinopril 10mg Details: one tablet taken orally per day for an average of 12 months. Eligible patients will be randomised to treatment with the polypill or to continue usual care. Subjects randomised to the polypill will only take one version of

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results