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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT04262206

Registry updated: 2026-09-01
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Description

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.

Interventions

  • Atorvastatin 40 Mg Oral Tablet (Drug)
    To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
  • Placebo oral tablet (Drug)
    To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

Eligibility criteria

Inclusion Criteria: * Community-dwelling adults * Age ≥75 years * English or Spanish as primary language * Able to provide a trusted contact 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) * 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

Conditions

Cognitive Impairment, Mild Dementia Cardiovascular Diseases

Locations

  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Birmingham VA — Birmingham, Alabama, United States
  • Southern Arizona VA Health Care System - Tucson — Tucson, Arizona, United States
  • Little Rock VA Medical Center — Little Rock, Arkansas, United States
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
  • Fresno VA Medical Center — Fresno, California, United States
  • Long Beach VA Medical Center — Long Beach, California, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • VA Greater Los Angeles — Los Angeles, California, United States
  • VA Northern California Health Care System — Mather, California, United States
  • VA Palo Alto Healthcare System — Palo Alto, California, United States
  • VA San Diego Medical Center — San Diego, California, United States
  • Yale University — New Haven, Connecticut, United States
  • VA Connecticut Healthcare System — West Haven, Connecticut, United States
  • Bay Pines VA — Bay Pines, Florida, United States
  • Gainesville VA Medical Center — Gainesville, Florida, United States
  • University of Florida — Gainesville, Florida, United States
  • University of Florida — Jacksonville, Florida, United States
  • Miami VA Medical Center — Miami, Florida, United States
  • University of Miami — Miami, Florida, United States
  • Atlanta VA Medical Center — Atlanta, Georgia, United States
  • Emory University — Atlanta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • University of Illinois at Chicago — Chicago, Illinois, United States
  • Chicago VA Medical Center/Jesse Brown VA — Chicago, Illinois, United States
  • Rush University Medical Center — Chicago, Illinois, United States
  • University of Chicago — Chicago, Illinois, United States
  • Hines VA Medical Center — Hines, Illinois, United States
  • North Chicago VA Medical Center — North Chicago, Illinois, United States
  • Indianapolis VA Medical Center — Indianapolis, Indiana, United States
  • University of Iowa Healthcare — Iowa City, Iowa, United States
  • University of Kansas Medical Center — Kansas City, Kansas, United States
  • VA Eastern Kansas Healthcare System — Topeka, Kansas, United States
  • Louisville VA Medical Center — Louisville, Kentucky, United States
  • University Medical Center — New Orleans, Louisiana, United States
  • Ochsner Clinic Foundation — New Orleans, Louisiana, United States
  • Maine VA Health Care System — Togus, Maine, United States
  • Johns Hopkins University — Baltimore, Maryland, United States
  • VA Boston Healthcare System — Boston, Massachusetts, United States
  • VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
  • University of Michigan — Ann Arbor, Michigan, United States
  • Essentia Health — Duluth, Minnesota, United States
  • Allina Health — Minneapolis, Minnesota, United States
  • Minneapolis VA Health Care System — Minneapolis, Minnesota, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • VA Medical Center Jackson — Jackson, Mississippi, United States
  • University of Missouri Health System — Columbia, Missouri, United States
  • Kansas City VA Medical Center — Kansas City, Missouri, United States
  • St. Louis VA Medical Center — St Louis, Missouri, United States
  • Washington University in St. Louis — St Louis, Missouri, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Omaha VA Medical Center — Omaha, Nebraska, United States
  • Reno VA/Sierra Nevada Health Care — Reno, Nevada, United States
  • Northwell Health — Manhasset, New York, United States
  • VA Hudson Valley Healthcare System — Montrose, New York, United States
  • VA New York Harbor Healthcare System — New York, New York, United States
  • Weill Cornell Medical College — New York, New York, United States
  • Albert Einstein College of Medicine — The Bronx, New York, United States
  • Bronx VA Medical Center — The Bronx, New York, United States
  • Asheville VA-Charles George VA Medical Center — Asheville, North Carolina, United States
  • University of North Carolina — Chapel Hill, North Carolina, United States
  • Atrium Health — Charlotte, North Carolina, United States
  • PREVENTABLE Tele-Site — Durham, North Carolina, United States
  • Durham VA Medical Center — Durham, North Carolina, United States
  • Duke University — Durham, North Carolina, United States
  • Duke University - Kannapolis — Kannapolis, North Carolina, United States
  • Wake Forest Baptist Hospital-Cardiology — Winston-Salem, North Carolina, United States
  • Wake Forest Hospital - Geriatrics — Winston-Salem, North Carolina, United States
  • Cincinnati VA Medical Center — Cincinnati, Ohio, United States
  • Case Western Reserve University — Cleveland, Ohio, United States
  • Ohio State University — Columbus, Ohio, United States
  • Dayton VA Medical Center — Dayton, Ohio, United States
  • Oregon Health and Science University — Portland, Oregon, United States
  • Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA — Philadelphia, Pennsylvania, United States
  • Thomas Jefferson University — Philadelphia, Pennsylvania, United States
  • University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
  • Providence VA Medical Center — Providence, Rhode Island, United States
  • Charleston VA Medical Center — Charleston, South Carolina, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Columbia VA Health Care System/Dorn VA Medical Center — Columbia, South Carolina, United States
  • VA Medical Center Memphis — Memphis, Tennessee, United States
  • Meharry Medical College — Nashville, Tennessee, United States
  • Nashville VA Medical Center — Nashville, Tennessee, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Baylor Scott and White Medical Center — Dallas, Texas, United States
  • Dallas VA Medical Center — Dallas, Texas, United States
  • University of Texas Southwestern Medical Center Dallas — Dallas, Texas, United States
  • Doctors Hospital at Renaissance — Edinburg, Texas, United States
  • University of Texas at Houston — Houston, Texas, United States
  • San Antonio VA Medical Center — San Antonio, Texas, United States
  • University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
  • Intermountain — Murray, Utah, United States
  • University of Utah — Salt Lake City, Utah, United States
  • VA Salt Lake City Healthcare System — Salt Lake City, Utah, United States
  • McGuire VA Medical Center — Richmond, Virginia, United States
  • Clarksburg VA Medical Center — Clarksburg, West Virginia, United States
  • Mayo Clinic Health Systems - NW Wisconsin — Eau Claire, Wisconsin, United States
  • Mayo Clinic Health System SW Wisconsin — La Crosse, Wisconsin, United States
  • Madison VA Medical Center — Madison, Wisconsin, United States
  • University of Wisconsin at Madison — Madison, Wisconsin, United States
  • Marshfield Clinic — Marshfield, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Milwaukee VA Medical Center — Milwaukee, Wisconsin, United States
  • VA Caribbean Healthcare System — San Juan, Puerto Rico, Puerto Rico
  • VA Carribbean Healthcare — San Juan, Puerto Rico, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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