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Trial registered on ANZCTR


Registration number
ACTRN12608000583347
Ethics application status
Approved
Date submitted
8/10/2008
Date registered
21/11/2008
Date last updated
1/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 282050 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Kanyini GAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 3803 0
High Risk Cardiovascular Disease 288523 0
Medication Adherence 288524 0
Condition category
Condition code
Cardiovascular 3984 3984 0 0
Other cardiovascular diseases
Cardiovascular 288855 288855 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 3524 0
Prevention
Intervention code [2] 286642 0
Treatment: Drugs
Comparator / control treatment
Usual care: separate cardiovascular preventive medications (e.g. antiplatelet, blood pressure lowering and cholesterol lowering medicines) as prescribed by the General Practitioner (GP). Duration of the treatment will be for an average of 12 months.
Control group
Active

Outcomes
Primary outcome [1] 4886 0
Adherence: Self-reported current use of antiplatelet, statin, and combination (2 or more) blood pressure lowering therapy
Timepoint [1] 4886 0
end of study (average 12 months)
Primary outcome [2] 4887 0
Change in blood pressure from baseline to the end of follow-up, measured by sphygmomanometer
Timepoint [2] 4887 0
Baseline visit, 12month visit, end of study visit (average 12 months)
Primary outcome [3] 4888 0
Change in total cholesterol from baseline to the end of follow-up as determined by blood analysis
Timepoint [3] 4888 0
Baseline visit, 12 month visit, end of study visit (average 18 months)
Secondary outcome [1] 8245 0
Adherence (defined as self reported current use of anti platelet, statin, and combination (2 or more) blood pressure lowering therapy as measured by an adherence questionnaire.
Timepoint [1] 8245 0
at 12 months
Secondary outcome [2] 8246 0
Prescribing of statin and (2 or more) blood pressure lowering agents collected from the patient records at the participant's General Practitioner.
Timepoint [2] 8246 0
End of study visit (average 12 months after randomisation)
Secondary outcome [3] 8247 0
Dispensing of statin and 2 or more blood pressure lowering agents measured using the dispensing records at participating pharmacies.
Timepoint [3] 8247 0
End of study visit (average 12 months after randomisation)
Secondary outcome [4] 8248 0
Cardiovascular events (self reported by patients, by the investigator or using the medical records at the participant General Practitioner). An Outcomes Adjudication Committee will review information about cardiovascular events reported
Timepoint [4] 8248 0
Collected any time between baseline visit and end of study visit (average 12 months after randomisation)
Secondary outcome [5] 8249 0
Serious adverse events (reported by the investigator or other site staff)
Timepoint [5] 8249 0
Collected any time between baseline visit and end of study visit (average 12 months after randomisation), recorded when the event occurs
Secondary outcome [6] 8250 0
Changes in other lipid fractions High-density Lipoprotein (HDL), calculated Low-density Lipoprotein (LDL), cholesterol, triglycerides) from baseline, as determined by blood analysis
Timepoint [6] 8250 0
Baseline visit and end of study visit
Secondary outcome [7] 257170 0
Renal events (new onset of microalbuminuria, progression from microalbuminuria to macroalbuminuria, 50% loss of estimated Glomerular Filtration Rate)
Timepoint [7] 257170 0
Baseline visit, 12month visit, end of study visit (average 12 months)
Secondary outcome [8] 257171 0
Reasons for stopping cardiovascular medications
Timepoint [8] 257171 0
Collected any time between baseline visit and end of study visit (average 12 months after randomisation)
Secondary outcome [9] 257172 0
Quality of Life (measured by EQ5D)
Timepoint [9] 257172 0
Baseline visit, 12month visit, end of study visit (average 12 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once subjects have been identified as high risk individuals the General Practitioner (GP) will arrange for clinical measures to assess cardiovascular disease (CVD) risk in order to confirm eligibility. If eligible, subjects will be allocated treatment using a central, computer based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3987 0
Government body
Name [1] 3987 0
National Health and Medical Research Council (NH&MRC)
Address [1] 3987 0
Level 5, 20 Allara St, Canberra City ACT 2601
Country [1] 3987 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 10, King George V (KGV) Building, Missenden Rd Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 3576 0
None
Name [1] 3576 0
Address [1] 3576 0
Country [1] 3576 0
Other collaborator category [1] 448 0
Other
Name [1] 448 0
Baker IDI Heart and Diabetes Institute
Address [1] 448 0
4/19 Hartley St Alice Springs NT 0870
Country [1] 448 0
Australia
Other collaborator category [2] 815 0
University
Name [2] 815 0
Monash University
Address [2] 815 0
Caulfield Hospital
Grnd Floor, Fethers Block
260 Kooyong Road
Caulfield 3162
Country [2] 815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6062 0
Sydney South West Area Health Service (SSWAHS) Ethics Review Committee (Royal Prince Alfred Hospital - RPAH zone)
Ethics committee address [1] 6062 0
Research Development Office, Page Pavilion
Level 8, Building 14, RPA Hospital
Missenden Rd, Camperdown, NSW 2050
Ethics committee country [1] 6062 0
Australia
Date submitted for ethics approval [1] 6062 0
Approval date [1] 6062 0
09/04/2008
Ethics approval number [1] 6062 0
08/RPAH/126

Summary
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.
Trial website
www.kvc.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29017 0
Prof Anushka Patel
Address 29017 0
Level 10, King George V (KGV) Building, Missenden Rd Camperdown 2050 NSW
Country 29017 0
Australia
Phone 29017 0
+61 2 99934500
Fax 29017 0
Email 29017 0
apatel@george.org.au
Contact person for public queries
Name 12174 0
Prof Anushka Patel
Address 12174 0
Level 10, King George V (KGV) Building, Missenden Rd Camperdown 2050 NSW
Country 12174 0
Australia
Phone 12174 0
+61 2 99934500
Fax 12174 0
Email 12174 0
apatel@george.org.au
Contact person for scientific queries
Name 3102 0
Prof Anushka Patel
Address 3102 0
Level 10, King George V (KGV) Building, Missenden Rd Camperdown 2050 NSW
Country 3102 0
Australia
Phone 3102 0
+61 2 99934500
Fax 3102 0
Email 3102 0
apatel@george.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary