CompletedPhase 3ACTRN12608000583347

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.

Sponsor

The George Institute for Global Health

Enrollment

1,000 participants

Start Date

Oct 31, 2009

Study Type

Interventional

Conditions

Medication Adherence High Risk Cardiovascular Disease

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a single daily 'polypill' combining several heart medications works better than taking each medication separately for people at high risk of heart disease or stroke. It is for adults aged 18 and older who have a history of cardiovascular disease or are at high calculated risk. People who have allergies to any of the polypill ingredients cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 the polypill. This will be determined by the participant's General Practitioner (GP).