About this trial

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.

Eligibility criteria

Qualifiers

Community-dwelling adults

Age ≥75 years

English or Spanish as primary language

Able to provide a trusted contact

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Atorvastatin 40 Mg Oral Tablet
  • Placebo oral tablet

Treatment groups

20,000 Participants
are divided into 2 treatment groups

Locations

103
Puerto Rico
VA Carribbean Healthcare00921, San JuanPuerto Rico, Puerto Rico
United States
Alabama
Birmingham VA35233, Birmingham United States
University of Alabama at Birmingham35205, Birmingham United States
Arizona
Southern Arizona VA Health Care System - Tucson85723, Tucson United States

Sponsors and collaborators

Duke University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Wake Forest University Health Sciences

Collaborator