NCT02099123 · Phase 4 · ACTIVE NOT RECRUITING

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

This trial is testing whether a daily statin (atorvastatin 40 mg) helps healthy people aged 70 and over stay alive and disability-free longer, and have fewer heart attacks and strokes, compared with a placebo. It is a Phase 4 trial, meaning the drug is already approved, and researchers are studying a new use.

Eligibility criteria

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)
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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2024-11-21

View full record on ClinicalTrials.gov

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