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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Cognitive Impairment, Mild, Dementia, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT04262206

Run by

Duke University

People needed

20000

Starts

2020-09-01

Expected to finish

2026-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 75 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Community-dwelling adults
• Age ≥75 years
• English or Spanish as primary language
• Able to provide a trusted contact

You may not qualify if…

• 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)
• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)
• Hines VA Medical Center — Hines, Illinois, United States (enrolling)
• Birmingham VA — Birmingham, Alabama, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Southern Arizona VA Health Care System - Tucson — Tucson, Arizona, United States (enrolling)
• Long Beach VA Medical Center — Long Beach, California, United States (enrolling)
• Little Rock VA Medical Center — Little Rock, Arkansas, United States (enrolling)
• VA Greater Los Angeles — Los Angeles, California, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• VA San Diego Medical Center — San Diego, California, United States (enrolling)
• Fresno VA Medical Center — Fresno, California, United States (enrolling)
• VA Connecticut Healthcare System — West Haven, Connecticut, United States (enrolling)
• Bay Pines VA — Bay Pines, Florida, United States (enrolling)
• Gainesville VA Medical Center — Gainesville, Florida, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• University of Florida — Jacksonville, Florida, United States (enrolling)
• Miami VA Medical Center — Miami, Florida, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Atlanta VA Medical Center — Atlanta, Georgia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• North Chicago VA Medical Center — North Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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