Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults

• Status: Recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute on Aging (NIA); Wake Forest University Health Sciences
• Treatments: Atorvastatin

Criteria

Inclusion Criteria:

• Community-dwelling adults

• Age ≥75 years

• English or Spanish as primary language

Exclusion Criteria:

• Clinically evident cardiovascular disease defined as prior myocardial Infarction (MI), prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin (clinician determined)

• Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note:

History of heart failure in the absence of recent hospitalization or clinically evident cardiovascular disease is not an exclusion)

• Dementia (clinically evident or previously diagnosed)

• Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of urinary or bowel continence)

• Severe hearing impairment (preventing phone follow up)

• Unable to talk (preventing phone follow up)

• Severe visual impairment (preventing cognitive testing)

• Statin use in the past year or for longer than 5 years previously (participant reported)

• Ineligible to take atorvastatin 40 mg (clinician determined)

• Documented intolerance to statins

• Active Liver Disease

• Long-term use of daily colchicine, verapamil at any dose, or diltiazem at a dose >240mg/day.