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

Launched by MONASH UNIVERSITY · Mar 27, 2014

Keywords

ClinConnect Summary

The STAREE study is a clinical trial that is trying to find out if taking a medication called atorvastatin (a type of statin) can help healthy older adults, aged 70 and above, live longer without disabilities and reduce the chances of serious heart problems. In this study, some participants will receive the atorvastatin, while others will receive a placebo, which is a harmless pill that looks the same but has no active ingredients. This research is important because it may help improve the health and quality of life for the elderly.

To be eligible for the trial, participants must be men or women aged 70 or older who live independently in the community. They should be able to agree to join the study and meet certain health criteria, meaning they shouldn’t have a history of serious heart conditions, diabetes, or other major health issues. Participants can expect to be closely monitored throughout the trial to assess their health and any changes over time. It’s also important to note that people currently taking certain medications that affect how statins work, or those with specific health problems, cannot join the study.

Gender

ALL

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.