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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
28/03/2014
Date last updated
12/03/2019

Titles & IDs
Public title
A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
Scientific title
A Study of STAtins for Reducing Events in the Elderly (STAREE)
Secondary ID [1] 0 0
NHMRC 1068146
Universal Trial Number (UTN)
Trial acronym
STAREE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Independent Living 0 0
Disability Free Survival 0 0
Elderly 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
(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.
Timepoint [1] 0 0
Time from randomisation to a primary endpoint
Secondary outcome [1] 0 0
Cardiovascular death - Fatal cardiovascular events
Timepoint [1] 0 0
From date of randomisation until the date of a death to a cardiovascular cause
Secondary outcome [2] 0 0
Fatal and Non-fatal Mycocardial infarction - Fatal and non-fatal
Timepoint [2] 0 0
From date of randomisation until the date of of diagnosis of a myocardial infarction
Secondary outcome [3] 0 0
Hospitalisations - Hospitalisation reasons and length of stay
Timepoint [3] 0 0
From date of randomisation until the date of hospitalisation
Secondary outcome [4] 0 0
New onset diabetes - New diagnosis of diabetes
Timepoint [4] 0 0
From date of randomisation until the date of diagnosis of diabetes
Secondary outcome [5] 0 0
Fatal and Non-fatal Cancer - Fatal and Non-fatal Cancer (excluding non-melanoma skin cancer)
Timepoint [5] 0 0
From date of randomisation until the date of death due to cancer or date of first date of first cancer event
Secondary outcome [6] 0 0
Cognitive decline - Cognitive decline as assessed using the 3MS excluding depression
Timepoint [6] 0 0
From date of randomisation until the date of a change in the 3Ms resulting in a diagnosis of cognitive decline
Secondary outcome [7] 0 0
Quality of life measured by the Short Form Health Survey (SF-36) - Quality of life (measured by the Short Form Health Survey (SF-36) administered at every second year of follow-up).
Timepoint [7] 0 0
Assessed annually
Secondary outcome [8] 0 0
Cost-effectiveness of statin - Cost-effectiveness of statin
Timepoint [8] 0 0
Up to 60 months
Secondary outcome [9] 0 0
Fatal and Non-fatal Stroke - Fatal and Non-fatal Stroke can be a) haemorrhagic or b) thromboembolic
Timepoint [9] 0 0
From date of randomisation until the date of a diagnoses stroke
Secondary outcome [10] 0 0
Approved need for permanent residential care - ACAS report
Timepoint [10] 0 0
Approved need for residential care as reported by the Aged care assessment team
Secondary outcome [11] 0 0
All cause dementia - All-cause dementia (COWAT, Stroop test, Trail Making Test, HVLT-R, SDMT, ADAS-Cog, Lurian overlapping figures)
Timepoint [11] 0 0
All cause dementia as assessed by cognitive tests
Secondary outcome [12] 0 0
Frailty/Disability - KATZ-ADL administered every 6 months
Timepoint [12] 0 0
As assesed using the KATZ-ADL

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)
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
18000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC,WA
Recruitment hospital [1] 0 0
Tasmania - Hobart
Recruitment hospital [2] 0 0
Victoria - Melbourne
Recruitment hospital [3] 0 0
South Australia - Adelaide
Recruitment hospital [4] 0 0
Queensland - Brisbane
Recruitment hospital [5] 0 0
New South Wales - Newcastle
Recruitment hospital [6] 0 0
Western Australia - Perth
Recruitment postcode(s) [1] 0 0
- Hobart
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Newcastle
Recruitment postcode(s) [6] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Heart Foundation, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT02099123
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sophia Zoungas, MBBS, FRACP
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sophia Zoungas, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 1800 770 664
Fax 0 0
Email 0 0
staree@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02099123