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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02099123




Registration number
NCT02099123
Ethics application status
Date submitted
25/03/2014
Date registered
28/03/2014

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
Disability free survival - death or development of dementia or development of persistent physical disability
Timepoint [1] 0 0
Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Primary outcome [2] 0 0
Major cardiovascular events
Timepoint [2] 0 0
Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [1] 0 0
Cardiovascular death
Timepoint [1] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [2] 0 0
Fatal and Non-fatal Mycocardial infarction
Timepoint [2] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [3] 0 0
Hospitalisations
Timepoint [3] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [4] 0 0
Fatal and Non-fatal Cancer
Timepoint [4] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [5] 0 0
Other cognitive impairment
Timepoint [5] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [6] 0 0
Quality of life measured by the Short Form Health Survey (SF-36)
Timepoint [6] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [7] 0 0
Cost-effectiveness of statin
Timepoint [7] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [8] 0 0
Fatal and Non-fatal Stroke
Timepoint [8] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [9] 0 0
Approved need for permanent residential care
Timepoint [9] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [10] 0 0
Dementia
Timepoint [10] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [11] 0 0
Persistent physical disability
Timepoint [11] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [12] 0 0
All cause death
Timepoint [12] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [13] 0 0
Heart failure
Timepoint [13] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [14] 0 0
Atrial fibrillation
Timepoint [14] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcome [15] 0 0
Revascularisation procedure
Timepoint [15] 0 0
Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.

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
Sex
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, carotid stenosis, abdominal aortic aneurysm 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,
* 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
Active, not 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
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
9971
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
On completion of the trial, and after publication of the primary and secondary outcomes of the study, requests for access to de-identified data (to be provided through a secure online environment) may be submitted to the researchers located at the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02099123