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Trial registered on ANZCTR


Registration number
ACTRN12608000584336
Ethics application status
Approved
Date submitted
17/10/2008
Date registered
21/11/2008
Date last updated
3/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
GAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 3842 0
Condition category
Condition code
Cardiovascular 4032 4032 0 0
Other cardiovascular diseases

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 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 version of the polypill. This will be determined by the participant's General Practitioner (GP).
Intervention code [1] 3568 0
Prevention
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 18 months.
Control group
Active

Outcomes
Primary outcome [1] 4934 0
Adherence: Self-reported current use of antiplatelet, statin, and combination (2 or more) blood pressure lowering therapy
Timepoint [1] 4934 0
end of study (average 18 months)
Primary outcome [2] 4935 0
Change in blood pressure from baseline to the end of follow-up, measured by sphygmomanometer
Timepoint [2] 4935 0
Baseline visit, 12month visit, end of study visit
Primary outcome [3] 4936 0
Change in total cholesterol from baseline to the end of follow-up (average 18 months) as determined by blood analysis
Timepoint [3] 4936 0
Baseline visit, 12 month visit, end of study visit (average 18 months)
Secondary outcome [1] 8316 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] 8316 0
at 12 months
Secondary outcome [2] 8317 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] 8317 0
End of study visit (average 18 months after randomisation)
Secondary outcome [3] 8318 0
Dispensing of statin and (2 or more) blood pressure lowering agents measured using the dispensing records at participating pharmacies.
Timepoint [3] 8318 0
End of study visit (average 18 months after randomisation)
Secondary outcome [4] 8319 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] 8319 0
Collected any time between baseline visit and end of study visit (average 18 months after randomisation). It will be recorded when they occur.
Secondary outcome [5] 8320 0
Serious adverse events (reported by the investigator or other site staff)
Timepoint [5] 8320 0
Collected any time between baseline visit and end of study visit (average 18 months after randomisation), recorded when the event occurs
Secondary outcome [6] 8321 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] 8321 0
Baseline visit and end of study visit
Secondary outcome [7] 8322 0
Quality of life questionnaire
Timepoint [7] 8322 0
Baseline visit, 12 month and end of study visit

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to any components of the polypill - 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4021 0
Government body
Name [1] 4021 0
National Health and Medical Research Council (NHMRC)
Country [1] 4021 0
Australia
Primary sponsor type
Other
Name
The George Institute for International Health
Address
Level 10, King George V (KGV) Building, Missenden Rd Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 3614 0
None
Name [1] 3614 0
Address [1] 3614 0
Country [1] 3614 0
Other collaborator category [1] 451 0
University
Name [1] 451 0
CCRE Therapeutics, School of Public Health & Preventive Medicine
Address [1] 451 0
Postal address: Monash University, Alfred Hospital, Melbourne VIC 3004

Street Address: Level3, 89 Commercial Rd, Melbourne VIC 3004
Country [1] 451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6102 0
Sydney South West Area Health Service (SSWAHS) Ethics Review Committee, Royal Prince Alfred Hospital (RPAH) zone
Ethics committee address [1] 6102 0
Ethics committee country [1] 6102 0
Australia
Date submitted for ethics approval [1] 6102 0
Approval date [1] 6102 0
21/05/2008
Ethics approval number [1] 6102 0
08/RPAH/126

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29048 0
Address 29048 0
Country 29048 0
Phone 29048 0
Fax 29048 0
Email 29048 0
Contact person for public queries
Name 12205 0
Dr Anushka Patel
Address 12205 0
Level 10, King George V (KGV) Building, Missenden Rd Camperdown 2050 NSW
Country 12205 0
Australia
Phone 12205 0
+61 2 99934500
Fax 12205 0
Email 12205 0
apatel@george.org.au
Contact person for scientific queries
Name 3133 0
Dr Anushka Patel
Address 3133 0
Level 10, King George V (KGV) Building, Missenden Rd Camperdown 2050 NSW
Country 3133 0
Australia
Phone 3133 0
+61 2 99934500
Fax 3133 0
Email 3133 0
apatel@george.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.