RECRUITING

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

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Conditions

Cognitive Impairment, MildDementiaCardiovascular Diseasesstatinolder adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)

Quick Facts

Study Start:2020-09-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04262206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Community-dwelling adults
  2. * Age ≥75 years
  3. * English or Spanish as primary language
  4. * Able to provide a trusted contact
  1. * 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)
  2. * 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)
  3. * Dementia (clinically evident or previously diagnosed)
  4. * Dependence in any Katz Basic Activities of Daily Living \[ADL\] (with the exception of urinary or bowel continence)
  5. * Severe hearing impairment (preventing phone follow up)
  6. * Unable to talk (preventing phone follow up)
  7. * Statin use in the past year or for longer than 5 years previously (participant reported)
  8. * Ineligible to take atorvastatin 40 mg (clinician determined)
  9. * Documented intolerance to statins
  10. * Active Liver Disease

Contacts and Locations

Study Contact

Jennifer Hervey
CONTACT
919-668-1965
jennifer.hervey@duke.edu
Pamela Monds
CONTACT
9196688695
pamela.monds@duke.edu

Study Locations (Sites)

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
Saint Louis, Missouri, 63106
United States
Washington University in St. Louis
Saint 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
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Bronx VA Medical Center
Bronx, New York, 10468
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
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

Collaborators and Investigators

Sponsor: Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • statin
  • older adults

Additional Relevant MeSH Terms

  • Cognitive Impairment, Mild
  • Dementia
  • Cardiovascular Diseases