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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/show/NCT02099123
Registration number
NCT02099123
Ethics application status
Date submitted
25/03/2014
Date registered
27/03/2014
Date last updated
18/08/2017
Titles & IDs
Public title
A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
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Scientific title
A Study of STAtins for Reducing Events in the Elderly (STAREE)
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Secondary ID [1]
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NHMRC 1068146
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Universal Trial Number (UTN)
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Trial acronym
STAREE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Independent Living
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Disability Free Survival
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Elderly
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Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Placebo (for Atorvastatin)
Experimental: Atorvastatin - 40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily
Placebo Comparator: Placebo - Placebo (2 x 20 mg placebo) taken orally once daily
Treatment: Drugs: Atorvastatin
Atorvastatin 20 mg tablet
Treatment: Drugs: Placebo (for Atorvastatin)
Inactive pill manufactured to mimic Atorvastatin 20 mg tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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(i) to death or development of dementia (as measured by cognitive function tests) or development of disability (as measured by the KATZ ADL test), or (ii) to a major fatal or non-fatal cardiovascular event. - The primary endpoint is either the time from randomisation (i) to death or development of dementia (as measured by cognitive function tests) or development of disability (as measured by the KATZ ADL33 test), or (ii) to a major fatal or non-fatal cardiovascular event.
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Timepoint [1]
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Time from randomisation to a primary endpoint
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Secondary outcome [1]
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Cardiovascular death - Fatal cardiovascular events
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Timepoint [1]
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From date of randomisation until the date of a death to a cardiovascular cause
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Secondary outcome [2]
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Mycocardial infarction
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Timepoint [2]
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From date of randomisation until the date of of diagnosis of a myocardial infarction
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Secondary outcome [3]
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Hospitalisations - Hospitalisation reasons and length of stay
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Timepoint [3]
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From date of randomisation until the date of hospitalisation
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Secondary outcome [4]
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New onset diabetes - New diagnosis of diabetes
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Timepoint [4]
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From date of randomisation until the date of diagnosis of diabetes
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Secondary outcome [5]
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Fatal and Non-fatal Cancer - Fatal and Non-fatal Cancer (excluding non-melanoma skin cancer)
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Timepoint [5]
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From date of randomisation until the date of death due to cancer or date of first date of first cancer event
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Secondary outcome [6]
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Cognitive decline - Cognitive decline as assessed using the 3MS excluding depression
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Timepoint [6]
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From date of randomisation until the date of a change in the 3Ms resulting in a diagnosis of cognitive decline
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Secondary outcome [7]
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Quality of life - Quality of life (measured by the Short Form Health Survey (SF-36) administered at every second year of follow-up).
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Timepoint [7]
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Assessed annually
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Secondary outcome [8]
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Cost-effectiveness of statin - Cost-effectiveness of statin
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Timepoint [8]
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Up to 60 months
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Secondary outcome [9]
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Stroke - Stroke can be a) haemorrhagic or b) thromboembolic
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Timepoint [9]
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From date of randomisation until the date of a diagnoses stroke
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Secondary outcome [10]
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Approved need for permanent residential care - ACAS report
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Timepoint [10]
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Approved need for residential care as reported by the Aged care assessment team
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Secondary outcome [11]
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All cause dementia - All-cause dementia (COWAT, Stroop test, Trail Making Test, HVLT-R, SDMT, ADAS-Cog, Lurian overlapping figures)
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Timepoint [11]
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All cause dementia as assessed by cognitive tests
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Secondary outcome [12]
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Frailty/Disability - KATZ-ADL administered every 6 months
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Timepoint [12]
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As assesed using the KATZ-ADL
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Eligibility
Key inclusion criteria
- Men and women aged =70 years living independently in the community
- Willing and able to provide informed consent and accept the study requirements (Note:
competent physical ability to participate in the trial is assessed using the KATZ ADL
questionnaire)
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Minimum age
70
Years
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Maximum age
No limit
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Gender
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
A history of cardiovascular disease (defined as myocardial infarction, stroke, peripheral
vascular disease, angina, transient ischaemic attack, coronary artery angioplasty and/or
stenting, coronary artery bypass grafting or heart failure),
- A history of dementia or a 3MS score <78 on screening,
- A history of diabetes,
- Total cholesterol >7.5 mmol/L,
- Moderate or severe chronic kidney disease (persistent proteinuria (Urine
albumin:creatinine ratio >30mg/mmol or Urine protein:creatinine ratios >45 mg/mmol)45
and/or eGFR <45ml/min/1.73m2),
- Moderate or severe liver disease (persistent elevations of transaminases of more than
3 times the upper limit of the normal laboratory reference range),
- Serious inter-current illness likely to cause death within the next 5 years such as
terminal cancer or obstructive airways disease,
- Current participation in a clinical trial (Note: If yes, this is only an exclusion if
other trial involves taking a drug or another intervention)
- Absolute contraindication to statin therapy,
- Current use of statin therapy or other lipid lowering therapy for primary prevention
and unwilling to stop therapy,
- Current long term or permanent use of the following cytochrome P450 (CYP) 3A4
inhibitors : Amiodarone, Boceprevir, Cimetidine, Cyclosporin, Danazol, Fosamprenavir,
Indinavir, Lopinavir + Ritonavir, Erythromycin, Fluconazole, Itraconazole,
Ketoconazole.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint(s)
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2022
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Actual
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Sample size
Target
18000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS,VIC
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Recruitment hospital [1]
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Tasmania - Hobart
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Recruitment hospital [2]
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Victoria - Melbourne
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Recruitment hospital [3]
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Queensland - Brisbane
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Recruitment hospital [4]
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New South Wales - Newcastle
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Recruitment hospital [5]
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Western Australia - Perth
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Recruitment postcode(s) [1]
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- Hobart
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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- Newcastle
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Recruitment postcode(s) [5]
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- Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with
placebo will prolong overall survival or disability free survival amongst healthy elderly
people (=70 years).
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Trial website
https://clinicaltrials.gov/show/NCT02099123
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sophia Zoungas, MBBS, FRACP
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No data has been provided for results reporting
Summary results
Not applicable
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