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.

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000584336

Acronym

GAP

Enrollment

1000

Registered

2008-11-21

Start date

2009-04-01

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 GAP 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; 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. There is a merge of this trial with the Kanyini Polypill trial (of identical protocol and study design) into one trial to be renamed as 'Kanyini Guidelines Adherence with the Polypill (GAP)' trial under the ACTRN 12608000583347.

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 18 months. Version 2c - hydrochlorothiazide 12.5mg, aspirin 75mg, simvastatin 40mg, lisinopril 10mg Details: one tablet taken orally per day for an average of 18 months. Eligible patients will be randomised to treatment with the polypill or to continued usual care. Subjects randomised to the polypill will only take one vers

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 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

Exclusion criteria

- Contraindication to any components of the polypill - the responsible clinician feels change to current therapy will place a patient at risk

Outcome results