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Trial registered on ANZCTR


Registration number
ACTRN12612000980831
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
11/09/2012
Date last updated
9/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the impact of a four-in-one 'polypill' on adherence to essential medications in those at highest risk of cardiovascular disease
Scientific title
Meta-analysis of trials assessing combination therapy to improve adherence to essential medications in patients with established disease or at high risk of cardiovascular disease
Secondary ID [1] 281197 0
nil
Universal Trial Number (UTN)
Trial acronym
Single Pill to Avert Cardiovascular Events Collaboration (SPACE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 287376 0
Condition category
Condition code
Cardiovascular 287710 287710 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants in the active arm of each trial have been allocated to either Red Heart Pill Version 1c (40mg simvastatin, 75mg aspirin, 10mg lisinopril, 50mg atenolol) once daily for duration of trial or
Red Heart Pill Version 2c (40mg simvastatin, 75mg aspirin, 10mg lisinopril, 12.5mg hydrochlorothiazide) once daily for duration of trial. The version prescribed is according to the physician's discretion. Each trial has an average of between 12 and 18 months follow-up. The main objective is to determine if combining 4 medications into one pill improves adherence to these medications.
Intervention code [1] 285660 0
Not applicable
Comparator / control treatment
The comparator in each of the trials included in the meta-analysis is 'usual care' which is defined as whatever treatment the treating physician deems appropriate for that patient's circumstances.
Control group
Active

Outcomes
Primary outcome [1] 287955 0
Self-reported current use of antiplatelet, statin, and combination (>= 2) blood pressure lowering therapy. Current use of a medication will be defined as taking the medication for at least 4 days during the week preceding the visit
Timepoint [1] 287955 0
12 months
Primary outcome [2] 287956 0
Change in systolic blood pressure
Timepoint [2] 287956 0
12 months
Primary outcome [3] 287957 0
Mean change in LDL cholesterol from baseline
Timepoint [3] 287957 0
12 months
Secondary outcome [1] 299118 0
Mean changes in Total cholesterol and other lipid fractions (HDL-cholesterol, triglycertides, non-HDL cholesterol) from baseline
Timepoint [1] 299118 0
12 months
Secondary outcome [2] 299119 0
Change in diastolic blood pressure
Timepoint [2] 299119 0
12 months
Secondary outcome [3] 299120 0
Self-reported current use (defined as at least four days in the week preceding the visit) of antiplatelet, statin, and at least one blood pressure lowering therapy
Timepoint [3] 299120 0
12 months
Secondary outcome [4] 299121 0
Changes in plasma creatinine
Timepoint [4] 299121 0
12 months
Secondary outcome [5] 299122 0
Quality of life (EQ5D)
Timepoint [5] 299122 0
12 months
Secondary outcome [6] 299123 0
Cardiovascular, non-cardiovascular and all-cause mortality
Timepoint [6] 299123 0
End of study
Secondary outcome [7] 299124 0
New onset Diabetes Mellitus. Defined as new diagnosis of Diabetes Mellitus as recorded in trial documentation or fasting plasma glucose > 7.0 mmol/L during the study period.
Timepoint [7] 299124 0
End of study
Secondary outcome [8] 299125 0
Cardiovascular events, defined as a composite of: (i) All coronary heart disease events including death from coronary heart disease, sudden cardiovascular death, non-fatal myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting) and hospitalisation for unstable angina; (ii) All heart failure events leading to death or requiring hospital admission. (iii) All cerebrovascular disease events including death from cerebrovascular disease, non-fatal stroke, transient ischaemic attack and sub-arachnoid haemorrhage (iv) All peripheral arterial events, including death due to peripheral vascular disease, new symptomatic claudication, amputation due to ischaemia, dissection, and peripheral arterial revascularisation procedures (such as: carotid endarterectomy or stent, open repair or stenting of aortic aneurysm or dissection, limb revascularisation, e.g. femoral-popliteal bypass surgery) or new onset chronic leg ulceration due to arterial insufficiency (v) CV events with and without procedures
Timepoint [8] 299125 0
End of study
Secondary outcome [9] 299126 0
Each of the four components of the secondary cardiovascular endpoint as described in Secondary Outcome 8
Timepoint [9] 299126 0
End of study

Eligibility
Key inclusion criteria
All patients included in SPACE Collaboration trials
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
As per the individual trials

Study design
Purpose
Duration
Selection
Timing
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)
Recruitment outside Australia
Country [1] 4541 0
New Zealand
State/province [1] 4541 0
Country [2] 4542 0
Ireland
State/province [2] 4542 0
Country [3] 4543 0
Netherlands
State/province [3] 4543 0
Country [4] 4544 0
India
State/province [4] 4544 0
Country [5] 4545 0
United Kingdom
State/province [5] 4545 0

Funding & Sponsors
Funding source category [1] 285977 0
Commercial sector/Industry
Name [1] 285977 0
Dr Reddy's Laboratories
Address [1] 285977 0
Door No 8-2-337,
Road No 3, Banjara Hills,
Hyderabad - 500034.
Andhra Pradesh
Country [1] 285977 0
India
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 10, KGV Building
Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 284797 0
None
Name [1] 284797 0
Address [1] 284797 0
Country [1] 284797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288010 0
Ethics committee address [1] 288010 0
Ethics committee country [1] 288010 0
Date submitted for ethics approval [1] 288010 0
21/05/2008
Approval date [1] 288010 0
Ethics approval number [1] 288010 0

Summary
Brief summary
An international collaboration of investigators has been established with the aim of assessing the benefits and risks of polypill-based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are planned, as the effectiveness and economic impact of a polypill-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered.
Primary outcomes for the individual patient data meta-analysis will include self-reported current use of antiplatelet, statin, and combination (>= 2) blood pressure lowering therapy at 12 months, and change in systolic blood pressure (SBP) and total cholesterol from baseline to 12 months. Non-inferiority margins of 3mmHg for SBP and 0.3 mmol/L for total cholesterol have been pre-specified.
Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of Life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34692 0
Prof Anthony Rodgers
Address 34692 0
The George Institute for Global Health
PO Box M201
Missenden Rd
Camperdown NSW 2050
Australia
Country 34692 0
Australia
Phone 34692 0
+61 2 9657 0375
Fax 34692 0
Email 34692 0
arodgers@georgeinstitute.org.au
Contact person for public queries
Name 17939 0
Dr Ruth Webster
Address 17939 0
The George Institute for Global Health
PO Box M201
Missenden Rd,
Camperdown NSW 2050
Country 17939 0
Australia
Phone 17939 0
+61 2 9993 4557
Fax 17939 0
Email 17939 0
rwebster@georgeinstitute.org.au
Contact person for scientific queries
Name 8867 0
Dr Ruth Webster
Address 8867 0
The George Institute for Global Health
PO Box M201
Missenden Rd,
Camperdown NSW 2050
Country 8867 0
Australia
Phone 8867 0
+61 2 9993 4557
Fax 8867 0
Email 8867 0
rwebster@georgeinstitute.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