Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
PREVENTABLE
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
2 other identifiers
interventional
20,000
2 countries
103
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2020
Longer than P75 for phase_4
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 5, 2025
June 1, 2025
6.3 years
February 7, 2020
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patients without diagnosis of new dementia
Number of patients without diagnosis of new dementia in each group (placebo vs. atorvastatin)
4 years
Number of patients without of persistent disability
Number of patients without chronic disability in each group
4 years
Secondary Outcomes (2)
Cardiovascular mortality measured as a composite of CV death, hospitalization for myocardial infarction/unstable angina, heart failure, stroke/TIA, or coronary revascularization
4 years
Cognitive disability as measured as a composite of MCI or probable dementia
4 years
Study Arms (2)
atorvastatin 40mg
EXPERIMENTAL40mg atorvastatin po qd from consent to study end
Placebo
PLACEBO COMPARATORmatching placebo po qd from consent to study end
Interventions
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
Eligibility Criteria
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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute on Aging (NIA)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Wake Forest University Health Sciencescollaborator
Study Sites (103)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Birmingham VA
Birmingham, Alabama, 35233, United States
Southern Arizona VA Health Care System - Tucson
Tucson, Arizona, 85723, United States
Little Rock VA Medical Center
Little Rock, Arkansas, 72114, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72204, United States
Fresno VA Medical Center
Fresno, California, 93703, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
VA Greater Los Angeles
Los Angeles, California, 90073, United States
VA Palo Alto Healthcare System
Palo Alto, California, 94550, United States
VA San Diego Medical Center
San Diego, California, 92161, United States
Yale University
New Haven, Connecticut, 06520, United States
VA Connecticut Healthcare System
West Haven, Connecticut, 006111, United States
Bay Pines VA
Bay Pines, Florida, 33744, United States
Gainesville VA Medical Center
Gainesville, Florida, 32608, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Florida
Jacksonville, Florida, 32608, United States
Miami VA Medical Center
Miami, Florida, 33125, United States
University of Miami
Miami, Florida, 33136, United States
Atlanta VA Medical Center
Atlanta, Georgia, 30033, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60208, United States
University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Chicago VA Medical Center/Jesse Brown VA
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Hines VA Medical Center
Hines, Illinois, 60141, United States
North Chicago VA Medical Center
North Chicago, Illinois, 60064, United States
Indianapolis VA Medical Center
Indianapolis, Indiana, 46202, United States
University of Iowa Healthcare
Iowa City, Iowa, 52242, United States
Kansas City VA Medical Center
Kansas City, Kansas, 64128, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
VA Eastern Kansas Healthcare System
Topeka, Kansas, 66622, United States
Louisville VA Medical Center
Louisville, Kentucky, 40206, United States
University Medical Center
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maine VA Health Care System
Togus, Maine, 04330, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
VA Boston Healthcare System
Boston, Massachusetts, 002130, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Essentia Health
Duluth, Minnesota, 55805, United States
Allina Health
Minneapolis, Minnesota, 55407, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
VA Medical Center Jackson
Jackson, Mississippi, 39216, United States
University of Missouri Health System
Columbia, Missouri, 65212, United States
St. Louis VA Medical Center
St Louis, Missouri, 63106, United States
Washington University in St. Louis
St Louis, Missouri, 63130, United States
University of Nebraska Medical Center
Omaha, Nebraska, 67105, United States
Omaha VA Medical Center
Omaha, Nebraska, 68105, United States
Reno VA/Sierra Nevada Health Care
Reno, Nevada, 89502, United States
Northwell Health
Manhasset, New York, 11030, United States
VA Hudson Valley Healthcare System
Montrose, New York, 10548, United States
VA New York Harbor Healthcare System
New York, New York, 10010, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Bronx VA Medical Center
The Bronx, New York, 10468, United States
Asheville VA-Charles George VA Medical Center
Asheville, North Carolina, 28805, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Atrium Health
Charlotte, North Carolina, 28207, United States
PREVENTABLE Tele-Site
Durham, North Carolina, 27701, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Duke University - Kannapolis
Kannapolis, North Carolina, 28081, United States
Wake Forest Baptist Hospital-Cardiology
Winston-Salem, North Carolina, 27157, United States
Wake Forest Hospital - Geriatrics
Winston-Salem, North Carolina, 27157, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
Dayton VA Medical Center
Dayton, Ohio, 45428, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Providence VA Medical Center
Providence, Rhode Island, 002908, United States
Charleston VA Medical Center
Charleston, South Carolina, 29401, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Columbia VA Health Care/Dorn VA Medical Center
Columbia, South Carolina, 29209, United States
VA Medical Center Memphis
Memphis, Tennessee, 38104, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Nashville VA Medical Center
Nashville, Tennessee, 37212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor Scott and White Medical Center
Dallas, Texas, 75210, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390, United States
Doctors Hospital at Renaissance
Edinburg, Texas, 78539, United States
University of Texas at Houston
Houston, Texas, 77204, United States
San Antonio VA Medical Center
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84132, United States
VA Salt Lake City Healthcare System
Salt Lake City, Utah, 84148, United States
Richmond VA
Richmond, Virginia, 23219, United States
Clarksburg VA Medical Center
Clarksburg, West Virginia, 26301, United States
Mayo Clinic Health Systems - NW Wisconsin
Eau Claire, Wisconsin, 54703, United States
Mayo Clinic Health System SW Wisconsin
La Crosse, Wisconsin, 54601, United States
VA Madison Healthcare System
Madison, Wisconsin, 53705, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53295, United States
Milwaukee VA Medical Center
Milwaukee, Wisconsin, 53295, United States
VA Carribbean Healthcare
San Juan, 00921, Puerto Rico
Related Publications (3)
Speiser JL, Ambrosius WT, Pajewski NM. Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials. Clin Trials. 2023 Oct;20(5):507-516. doi: 10.1177/17407745231177046. Epub 2023 May 26.
PMID: 37243355DERIVEDJoseph J, Pajewski NM, Dolor RJ, Sellers MA, Perdue LH, Peeples SR, Henrie AM, Woolard N, Jones WS, Benziger CP, Orkaby AR, Mixon AS, VanWormer JJ, Shapiro MD, Kistler CE, Polonsky TS, Chatterjee R, Chamberlain AM, Forman DE, Knowlton KU, Gill TM, Newby LK, Hammill BG, Cicek MS, Williams NA, Decker JE, Ou J, Rubinstein J, Choudhary G, Gazmuri RJ, Schmader KE, Roumie CL, Vaughan CP, Effron MB, Cooper-DeHoff RM, Supiano MA, Shah RC, Whittle JC, Hernandez AF, Ambrosius WT, Williamson JD, Alexander KP; PREVENTABLE Trial Research Group. Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale. J Am Geriatr Soc. 2023 Jun;71(6):1701-1713. doi: 10.1111/jgs.18312. Epub 2023 Apr 20.
PMID: 37082807DERIVEDRozing MP, Westendorp RGJ. Altered cardiovascular risk pattern of LDL cholesterol in older adults. Curr Opin Lipidol. 2023 Feb 1;34(1):22-26. doi: 10.1097/MOL.0000000000000859. Epub 2022 Nov 16.
PMID: 36413436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 10, 2020
Study Start
September 1, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share