A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)

NCT02099123 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: NHMRC 1068146
• Study Type: interventional
• Target: 9,971
• Locations: 1 country
• Sites: 6

Brief Summary

The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years).

Conditions

Independent Living; Disability Free Survival; Elderly; Healthy

Keywords

Survival; Functional Disability; Cardiovascular Disease; Diabetes; Dementia; Cancer

Outcome Measures

Primary Outcomes (2)

• Disability free survival - death or development of dementia or development of persistent physical disability

  Defined as survival free of dementia or persistent physical disability (as derived from the endpoints of all-cause mortality, dementia and physical disability)

  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.

• Major cardiovascular events

  Defined as the first occurrence of a cardiovascular death or a non-fatal myocardial infarction or stroke or coronary revascularisation

  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 Outcomes (16)

• A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke

  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.

• Cardiovascular death

  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.

• Fatal and Non-fatal Mycocardial infarction

  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.

• Hospitalisations

  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.

• Fatal and Non-fatal Cancer

  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.

Other Outcomes (1)

• New onset diabetes

  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.

Study Arms (2)

Atorvastatin

EXPERIMENTAL

40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Placebo (2 x 20 mg placebo) taken orally once daily

Drug: Placebo (for Atorvastatin)

Interventions

Atorvastatin DRUG

Atorvastatin 20 mg tablet

Also known as: Lipitor, , , Cadivast, Caduet, Lorstat, Torvastat, Trovas, Atorachol, Cadatin

Atorvastatin

Placebo (for Atorvastatin) DRUG

Inactive pill manufactured to mimic Atorvastatin 20 mg tablet

Also known as: no other names

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead
• National Health and Medical Research Council, Australia: collaborator
• National Heart Foundation, Australia: collaborator

Study Sites (6)

Tasmania

Hobart, Tasmania, Australia

Location

Victoria

Melbourne, Victoria, Australia

Location

South Australia

Adelaide, Western Australia, Australia

Location

Queensland

Brisbane, Australia

Location

New South Wales

Newcastle, Australia

Location

Western Australia

Perth, Australia

Location

Related Publications (3)

• Zoungas S, Moran C, Curtis AJ, Spark S, Flanagan Z, Beilin L, Chong TT, Cloud GC, Hopper I, Kost A, McNeil JJ, Nicholls SJ, Reid CM, Ryan J, Tonkin AM, Ward S, Wierzbicki AS, Wolfe R, Zhou Z, Nelson MR; STAREE investigator group. Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability-Free Survival in Older People. J Am Heart Assoc. 2024 Nov 19;13(22):e036357. doi: 10.1161/JAHA.124.036357. Epub 2024 Nov 15.

  PMID: 39548016 DERIVED

• Zoungas S, Curtis A, Spark S, Wolfe R, McNeil JJ, Beilin L, Chong TT, Cloud G, Hopper I, Kost A, Nelson M, Nicholls SJ, Reid CM, Ryan J, Tonkin A, Ward SA, Wierzbicki A; STAREE investigator group. Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial). BMJ Open. 2023 Apr 3;13(4):e069915. doi: 10.1136/bmjopen-2022-069915.

  PMID: 37012015 DERIVED

• Rozing MP, Westendorp RGJ. Altered cardiovascular risk pattern of LDL cholesterol in older adults. Curr Opin Lipidol. 2023 Feb 1;34(1):22-26. doi: 10.1097/MOL.0000000000000859. Epub 2022 Nov 16.

  PMID: 36413436 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Dementia; Neoplasms

Interventions

Atorvastatin; amlodipine, atorvastatin drug combination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Sophia Zoungas, MBBS, FRACP

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sophia Zoungas

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)