Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized 1:1 atorvastatin 40mg vs. placebo
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
atorvastatin 40mg
40mg atorvastatin po qd from consent to study end
  • Drug: Atorvastatin 40 Mg Oral Tablet
    To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
    Other names:
    • Lipitor
Placebo Comparator
Placebo
matching placebo po qd from consent to study end
  • Drug: Placebo oral tablet
    To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35205
Contact:
Destiny Taylor
205-224-2567
destiny.taylor@uabmc.edu

Birmingham VA
Birmingham, Alabama 35233
Contact:
Donald Davis
205-933-8101
Donald.Davis@va.gov

Southern Arizona VA Health Care System - Tucson
Tucson, Arizona 85723
Contact:
Jordan Gonzalez
520-792-1450
Jordan.gonzalez@va.gov

Little Rock VA Medical Center
Little Rock, Arkansas 72114
Contact:
Bonnie Dawson
501-257-2523
Bonnie.Dawson2@va.gov

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72204
Contact:
Randy Henderson
501-603-1514
RAHenderson@uams.edu

Fresno VA Medical Center
Fresno, California 93703
Contact:
Kieu Chau
559-225-6100
Kieu.chau@va.gov

Long Beach VA Medical Center
Long Beach, California 90822
Contact:
Christina Hy
562-826-5449
christina.hy@va.gov

VA Greater Los Angeles
Los Angeles, California 90073
Contact:
Angela Zeng
310-268-4110
angela.zeng@va.gov

VA San Diego Medical Center
San Diego, California 92161
Contact:
Melissa St. John
858-642-1129
Melissa.St.John@va.gov

Yale University
New Haven, Connecticut 06520
Contact:
Meilyn Madrigal
203-737-2252
meilyn.madrigal@yale.edu

VA Connecticut Healthcare System
West Haven, Connecticut 006111
Contact:
Study Coordinator
203-932-5711

Bay Pines VA
Bay Pines, Florida 33744
Contact:
Chayla Lee
727-398-6661
chayla.lee@va.gov

Gainesville VA Medical Center
Gainesville, Florida 32608
Contact:
Laura Dixon
352-548-7707
Laura.dixon1@va.gov

University of Florida
Gainesville, Florida 32610
Contact:
Monika Guirguis
352-273-5919
recruit@aging.ufl.edu

University of Florida
Jacksonville, Florida 32608
Contact:
Renae Burr
904-244-4690
JAX-ASCENT@jax.ufl.edu

Miami VA Medical Center
Miami, Florida 33125
Contact:
Jennifer Denizard
786-299-2139
jennifer.denizard@va.gov;

University of Miami
Miami, Florida 33136
Contact:
Yesenia Levi
786-877-7710
yxl878@miami.edu

Atlanta VA Medical Center
Atlanta, Georgia 30033
Contact:
Mechelle Lockhart
404-315-4100
Mechelle.lockhart@va.gov

Emory University
Atlanta, Georgia 30322
Contact:
William Brown
770-330-7790
mindandheart@emory.edu

Northwestern University
Chicago, Illinois 60208
Contact:
Holly Herman
312-503-4639
holly.herman@northwestern.edu

University of Illinois at Chicago
Chicago, Illinois 60608
Contact:
Naomi Ashley
312-355-0083
naomiab@uic.edu

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Erin Yurko
312-942-6596
erin_yurko@rush.edu

University of Chicago
Chicago, Illinois 60637
Contact:
Matt Carlson
210-908-7749
mcarlson1@medicine.bsd.uchicago.edu

Hines VA Medical Center
Hines, Illinois 60141
Contact:
Holly Kramer, MD
708-202-8387
Holy.Kramer@va.gov

North Chicago VA Medical Center
North Chicago, Illinois 60064
Contact:
Teresa Todela
224-610-1310
teresa.todela@va.gov

Indianapolis VA Medical Center
Indianapolis, Indiana 46202
Contact:
Lauren Espique
317-988-3304
Lauren.Espique@va.gov

University of Iowa Healthcare
Iowa City, Iowa 52242
Contact:
Tamara Lowe
319-384-8103
tamara-lowe@uiowa.edu

Kansas City VA Medical Center
Kansas City, Kansas 64128
Contact:
Shamsa Kiran
816-861-4700
Shamsa.Kiran@va.gov;

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Erica Lower
913-588-6052
elower@kumc.edu

Louisville VA Medical Center
Louisville, Kentucky 40206
Contact:
Jordan Ricks
502-287-5208
Jordan.Ricks@va.gov

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
Shannon Williams
504-842-6487
slwilliams@ochsner.org

Maine VA Health Care System
Togus, Maine 04330
Contact:
Vanessa Knipping
207-623-8411
Vanessa.Knipping@va.gov

Johns Hopkins University
Baltimore, Maryland 21287
Contact:
Megan Gauvey-Kern
443-242-4126
PREVENTABLE@jhmi.edu

VA Boston Healthcare System
Boston, Massachusetts 002130
Contact:
Enzo Yaksic
617-637-5139
Enzo.Yaksic@va.gov

VA Ann Arbor Healthcare System
Ann Arbor, Michigan 48105
Contact:
Carly Runge
734-845-3668
carly.runge@va.gov

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Martina Nabozny
734-385-6150
mgrenier@med.umich.edu

Essentia Health
Duluth, Minnesota 55805
Contact:
Leah Tatalovich
218-576-0506
PREVENTABLE@EssentiaHealth.org

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Angela Meilander
507-293-9539
RSTPREVENTSTUDY@mayo.edu

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Lane Boyer
601-815-8702
kboyer@umc.edu

VA Medical Center Jackson
Jackson, Mississippi 39216
Contact:
Anita K Spencer
601-362-4471
anita.spencer@va.gov

University of Missouri Health System
Columbia, Missouri 65212
Contact:
Vickie Grieshaber
833-499-1938
mupreventable@health.missouri.edu

St. Louis VA Medical Center
Saint Louis, Missouri 63106
Contact:
Socorro White
314-289-7690
Socorro.White@va.gov

Washington University in St. Louis
Saint Louis, Missouri 63130
Contact:
Amy Young
314-273-0338
amyyoung@wustl.edu

University of Nebraska Medical Center
Omaha, Nebraska 67105
Contact:
Amy Peterson
402-552-7737
preventable@unmc.edu

Omaha VA Medical Center
Omaha, Nebraska 68105
Contact:
Ramesh Ramalingam
402-995-4873
Ramesh.ramalingam@va.gov

Albert Einstein College of Medicine
Bronx, New York 10461
Contact:
Yessica E Vanterpool
718-430-3422
yessica.estrellavanterpool@einsteinmed.edu

Northwell Health
Manhasset, New York 11030
Contact:
Julie DiGregorio
516-493-7950
jdigregori@northwell.edu

Weill Cornell Medical College
New York, New York 10021
Contact:
Fernando Park
607-204-9070
preventable@med.cornell.edu

Asheville VA-Charles George VA Medical Center
Asheville, North Carolina 28805
Contact:
Mary Elizabeth Sigmon
828-298-7911
MaryElizabeth.Sigmon@va.gov

University of North Carolina
Chapel Hill, North Carolina 27599
Contact:
Jeannie Ake
919-966-9003
UNC_PREV@office.unc.edu

Atrium Health
Charlotte, North Carolina 28207
Contact:
Kelsey Strout
704-304-8394
preventablestudy@atriumhealth.org

PREVENTABLE Tele-Site
Durham, North Carolina 27701
Contact:
Khaula Baloch

Durham VA Medical Center
Durham, North Carolina 27705
Contact:
Julienne Reynolds
919-286-0411
Julienne.Reynolds@va.gov

Duke University
Durham, North Carolina 27710
Contact:
Trina Phan
919-684-9176
DukePREVENTABLE@duke.edu

Duke University - Kannapolis
Kannapolis, North Carolina 28081
Contact:
Jennifer Stiller
704-640-7616
preventable-kannapolis@dm.duke.edu

Wake Forest Baptist Hospital-Cardiology
Winston-Salem, North Carolina 27157
Contact:
Sophia Dawson
336-713-2338
sadawson@wakehealth.edu

Wake Forest Hospital - Geriatrics
Winston-Salem, North Carolina 27157
Contact:
Jesus Betancourt
336-713-8659
jbetanco@wakehealth.edu

Cincinnati VA Medical Center
Cincinnati, Ohio 45220
Contact:
Lora Morris
513-861-3100
Lora.Morris@va.gov

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Kelsey Ufholz
216-286-2212
Kelsey.Ufholz@uhhospitals.org

Ohio State University
Columbus, Ohio 43210
Contact:
Tait Palm
614-685-3089
preventable@osumc.edu

Dayton VA Medical Center
Dayton, Ohio 45428
Contact:
Tiffany Castle
937-268-6511
tiffany-castle@va.gov

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Emily Klawson
412-586-9796
klawson2@upmc.edu

Providence VA Medical Center
Providence, Rhode Island 002908
Contact:
Sarah Richer
401-273-7100
sarah.richter@va.gov

Charleston VA Medical Center
Charleston, South Carolina 29401
Contact:
Taylor Willis
843-789-7031
taylor.willis1@va.gov

Medical University of South Carolina
Charleston, South Carolina 29403
Contact:
Amy Reynolds
843-792-8459
muscpreventable@musc.edu

Columbia VA Health Care/Dorn VA Medical Center
Columbia, South Carolina 29209
Contact:
Ariana Tinker
803-776-4000
Ariana.tinker@va.gov

VA Medical Center Memphis
Memphis, Tennessee 38104
Contact:
Brandon Beaverson
901-523-8990
Brandon.Beaverson@va.gov

Meharry Medical College
Nashville, Tennessee 37208
Contact:
Steven Houtschilt
615-398-2741
shoutschilt@mmc.edu

Nashville VA Medical Center
Nashville, Tennessee 37212
Contact:
Jennifer Wharton
615-873-6055
Jennifer.Wharton@va.gov

Vanderbilt University Medical Center
Nashville, Tennessee 37212
Contact:
Jennifer Wharton
615-322-6191
jennifer.wharton@vumc.org

Baylor Scott and White Medical Center
Dallas, Texas 75210
Contact:
Kionna Henderson
214-865-3196
Kionna.Henderson@BSWHealth.org

Dallas VA Medical Center
Dallas, Texas 75216
Contact:
Jodie-Ann Clarke
214-857-0393
Jodie-ann.clarke@va.gov

University of Texas Southwestern Medical Center Dallas
Dallas, Texas 75390
Contact:
Gentina Thompson
214-648-0205
gentina.thompson@utsouthwestern.edu

Doctors Hospital at Renaissance
Edinburg, Texas 78539
Contact:
Esmeralda Cardosa-Mendoza
956-362-2391
e.cardosa@dhr-rgv.com

University of Texas at Houston
Houston, Texas 77204
Contact:
Paola Robles
713-500-7904
paola.roblescordova@uth.tmc.edu

San Antonio VA Medical Center
San Antonio, Texas 78229
Contact:
Amir Tavabi
tavabi@uthscsa.edu

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Kevin Brown
210-450-3045
Brownk5@uthscsa.edu

Intermountain
Murray, Utah 84107
Contact:
Tyler Winslow
801-507-4565
preventablestudy@imail.org

VA Salt Lake City Healthcare System
Salt Lake City, Utah 84148
Contact:
Stephen Thongsa
801-577-8524
Stephen.thongsa@va.gov

Richmond VA
Richmond, Virginia 23219
Contact:
Charmaine Taylor
804-675-5000
charmaine.taylor@va.gov

Mayo Clinic Health Systems - NW Wisconsin
Eau Claire, Wisconsin 54703
Contact:
Joshua Druckrey
715-838-5831
Druckrey.Joshua@mayo.edu

Mayo Clinic Health System SW Wisconsin
La Crosse, Wisconsin 54601
Contact:
Janel Tunison
608-392-6880
tunison.janel@mayo.edu

VA Madison Healthcare System
Madison, Wisconsin 53705
Contact:
Hannah Zylstra
608-256-1901
hannah.zylstra@va.gov

Marshfield Clinic
Marshfield, Wisconsin 54449
Contact:
Diane Kohnhorst
888-367-4413
PREVENTABLE@marshfieldresearch.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53295
Contact:
Madeline Berendt
414-805-7291
PREVENTABLE@mcw.edu

Milwaukee VA Medical Center
Milwaukee, Wisconsin 53295
Contact:
Julie Lorscheter
414-384-2000
julie.lorscheter@va.gov

VA Carribbean Healthcare
San Juan, Puerto Rico 00921
Contact:
William Rodriguez-Cintron, MD
787-641-7582
williams.rodriguez@va.gov

More Details

NCT ID
NCT04262206
Status
Recruiting
Sponsor
Duke University

Study Contact

Jennifer Hervey
919-668-1965
jennifer.hervey@duke.edu

Detailed Description

PREVENTABLE will randomly assign atorvastatin 40 mg daily or matching placebo daily to approximately 20,000 community-dwelling adults 75 years of age or older without clinically evident cardiovascular disease, significant disability, or dementia, and follow them for up to 5 years (estimated median of 3.8 years). The study will enroll participants from approximately 100 US sites. Community engagement efforts will leverage community groups and practices as collaborators for recruitment. We plan to partner with participants, caregivers, and clinicians in all aspects of the study. The enrolling sites are non-VA and VA sites. To assist in recruitment, sites will apply a study-specific cohort identification algorithm to their electronic health record to create a list of eligible participants based on study inclusion and exclusion criteria. The cohort identification will exclude individuals with clinically evident cardiovascular disease, significant disability, or dementia and other exclusions obtainable from data queries to define a potential cohort. Additionally, the PREVENTABLE CCC will provide a centralized support team to assist with recruitment and retention efforts. This includes mass mailings and/or phone calls to potential participants and a toll-free number for potential participants to call for information and pre-screening. Interested and potentially eligible participants will be referred to an enrolling site near them, if applicable, otherwise, they will be referred to the PREVENTABLE Telesite which is capable of enrolling English and Spanish-speaking participants across the U.S. remotely. Sites will screen potential participants to confirm eligibility and consent and randomize those interested in joining the study. Specifically related to dementia, the qualifying exclusion is a clinical diagnosis in the chart or clinician's assessment that dementia may be present. Sites will enter contact information, mailing address for study drug, demographic information, height, weight, statin history (if any), Social Security Number, and aspects of the medical history not obtainable from EHR. In addition, a Short Physical Performance Battery (SPPB) and Activities of Daily Living (ADL) screen will be site-performed at baseline. SPPB will provide an objective assessment of function for understanding frailty and physical function of the enrolled population. Baseline lipid panel (core lab) and biospecimen samples will be obtained using the same blood draw for 20cc of blood. Blinded lipid testing will be performed at baseline on all participants (n=20,000) and repeated at 3 months in a random subset (n=2,000). Lipid panels will be sent to the PREVENTABLE Core Lab to maintain study blind. Future testing of lipid panels during routine clinical care will be actively discouraged, but other laboratory testing as indicated by clinical care is permitted. Sites will have the option for telehealth enrollment. Baseline SPPB and Biorepository Labs are not required, but encouraged. As part of the study operations, with the rationale of providing patient centricity, ease of participation, and access for vulnerable and at risk participants, follow up will be performed by a central call center. The baseline and annual assessments performed centrally will include a phone screen for cognitive function (TICS-M) and physical function (Patient-reported Outcome Measurement Information System-Physical Function [PROMIS-PF]). After year 1, if baseline calls indicated by crossing pre-specified cutpoints, in-person assessments will be completed by trained and certified research staff at a mutually agreed upon time and a standardized interview of a knowledgeable informant. Cardiovascular event ascertainment will be via a systematic approach to data curation from the EHR, Medicare, and National Death Index. For convenience and compliance, the study pharmacy will mail a supply of study drug, sufficient for 90 days, directly to participants. This will start immediately after randomization and continue as long as the participant is on study drug.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.