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

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) - Severe visual impairment (preventing cognitive testing) - 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 - Long-term use of daily colchicine, verapamil at any dose, or diltiazem at a dose >240mg/day.

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

Birmingham VA
Birmingham, Alabama 35233
Contact:
Donald Davis
Donald.Davis@va.gov

Southern Arizona VA Health Care System - Tucson
Tucson, Arizona 85723
Contact:
Marivic Hansen
marivic.hansen@va.gov

Little Rock VA Medical Center
Little Rock, Arkansas 72114
Contact:
Melinda Bopp
Melinda.Bopp@va.gov

Fresno VA Medical Center
Fresno, California 93703
Contact:
Stacey Holtermann
Stacey.Holtermann@va.gov

Long Beach VA Medical Center
Long Beach, California 90822
Contact:
Shobha Kamanna
Shobha.kamanna@va.gov

VA Greater Los Angeles
Los Angeles, California 90073
Contact:
Daniel Fernadez
dmf.legacy@gmail.com

VA Palo Alto Healthcare System
Palo Alto, California 94550
Contact:
Kodash Thomas
manjula.tamura@va.gov

VA San Diego Medical Center
San Diego, California 92161
Contact:
Tiffany Hancock
Tiffany.hancock@va.gov

VA Connecticut Healthcare System
West Haven, Connecticut 006111
Contact:
Kasey Spreyer
kasey.spreyer@va.gov

Bay Pines VA
Bay Pines, Florida 33744
Contact:
Cortny Withee
cortny.withee@va.gov

Gainesville VA Medical Center
Gainesville, Florida 32608
Contact:
Juliana Venetucci
Juliana.Venetucci@va.gov

University of Florida
Gainesville, Florida 32610
Contact:
Megan Roberts
352-294-5090
mloro@ufl.edu

University of Florida
Jacksonville, Florida 32608
Contact:
Jennifer Bowman
904-244-4691
Jennifer.bowman@jax.ufl.edu

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

University of Miami
Miami, Florida 33136
Contact:
Veronica Linares
305-243-8905
vilnares@med.miami.edu

Atlanta VA Medical Center
Atlanta, Georgia 30033
Contact:
Jessica Kelleher
404-315-4100
Jessica.Kelleher@va.gov

University of Illinois at Chicago
Chicago, Illinois 60608
Contact:
Naomi Ashley
312-860-3180
naomiab@uic.edu

Chicago VA Medical Center/Jesse Brown VA
Chicago, Illinois 60612
Contact:
Jose Tenorio
jose.tenorio@va.gov

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:
Corliss Taylor
Corliss.Taylor@va.gov

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

Indianapolis VA Medical Center
Indianapolis, Indiana 46202
Contact:
Lauren Espique
Lauren.Espique@va.gov

University of Iowa Healthcare
Iowa City, Iowa 52242
Contact:
Tanya Stalder
319-335-6490
tanya-stalder@uiowa.edu

Kansas City VA Medical Center
Kansas City, Kansas 64128
Contact:
Shamsa Kiran
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:
Denise Zellars
Denise.Zellars@va.gov

University Medical Center
New Orleans, Louisiana 70112
Contact:
Bridget Lee
504-702-5494
bridget.lee@lcmchealth.org

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
Sarah Cohen
504-703-5605
sarah.cohen@ochsner.org

Johns Hopkins University
Baltimore, Maryland 21287
Contact:
Megan Gauvey-Kern
410-361-7881
mgauvey1@jhmi.edu

VA Boston Healthcare System
Boston, Massachusetts 002130
Contact:
Enzo Yaksic
Enzo.Yaksic@va.gov

VA Ann Arbor Healthcare System
Ann Arbor, Michigan 48105
Contact:
Pearl Lee
pearl.lee2@va.gov

Essentia Health
Duluth, Minnesota 55805
Contact:
Ryan Thiel
218-786-2077
ryan.thiel@essentiahealth.org

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Bayly Bucknell
507-538-7877
bucknell.bayly@mayo.edu

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Memrie Cochran
601-815-7003
mcochran1@umc.edu

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

University of Missouri Health System
Columbia, Missouri 65212
Contact:
Vickie Grieshaber
573-884-4099
grieshaberv@health.missouri.edu

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

University of Nebraska Medical Center
Omaha, Nebraska 67105
Contact:
Carol Geary
402-559-8446
carolr.geary@unmc.edu

Omaha VA Medical Center
Omaha, Nebraska 68105
Contact:
Ramesh Ramalingham
ramesh.ramalingam@va.gov

Albert Einstein College of Medicine
Bronx, New York 10461
Contact:
Nadia Persaud
718-920-8576
napersaud@montefiore.org

Weill Cornell Medical College
New York, New York 10021
Contact:
Turanoom Haque
646-962-8032
preventable@med.cornell.edu

Asheville VA-Charles George VA Medical Center
Asheville, North Carolina 28805
Contact:
Jessica Michael
Jessica.Michael@va.gov

University of North Carolina
Chapel Hill, North Carolina 27599
Contact:
Aiden Lefebvre
919-966-9003
aiden@live.unc.edu

Durham VA Medical Center
Durham, North Carolina 27705
Contact:
Kathy Aristy
Kathy.Aristy@va.gov

Duke University
Durham, North Carolina 27710
Contact:
Christina Faison
919-613-6773
christina.faison@duke.edu

Wake Forest Baptist Hospital
Winston-Salem, North Carolina 27157
Contact:
Christine O'Neil
coneill@wakehealth.edu

Cincinnati VA Medical Center
Cincinnati, Ohio 45220
Contact:
Julie Bunke
Julie.bunke2@va.gov

Ohio State University
Columbus, Ohio 43210
Contact:
Matthew Jindra
614-292-2655
matthew.jindra@osumc.edu

Dayton VA Medical Center
Dayton, Ohio 45428
Contact:
Donna Woerner
donna.woerner@va.gov

Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA
Philadelphia, Pennsylvania 19104
Contact:
Bruce Kinosian
bruce.kinosian@va.gov

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

Providence VA Medical Center
Providence, Rhode Island 002908
Contact:
Karen Evans
karen.evans7@va.gov

Charleston VA Medical Center
Charleston, South Carolina 29401
Contact:
Charnele Handy
charnele.Handy@va.gov

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

Monument Health
Rapid City, South Dakota 57701
Contact:
Amber Beer
605-755-4326

VA Medical Center Memphis
Memphis, Tennessee 38104
Contact:
brandon Beaverson
brandon.beaverson@va.gov

Meharry Medical College
Nashville, Tennessee 37208
Contact:
Steven Houtschilt
248-875-7668
shoutschilt@mmc.edu

Nashville VA Medical Center
Nashville, Tennessee 37212
Contact:
Jennifer Wharton
Jennifer.Wharton@va.gov

Vanderbilt University Medical Center
Nashville, Tennessee 37212
Contact:
Jennifer Wharton
615-873-6055
jennifer.wharton@vumc.org

Dallas VA Medical Center
Dallas, Texas 75216
Contact:
Amy Atwell
Amy.Awell@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:
Katelyn Villa
956-362-2391
k.villa@dhr-rgv.com

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:
Bryan Prieto
210-450-3045
prietob@uthscsa.edu

Baylor Scott and White Medical Center
Temple, Texas 76508
Contact:
Rohini Bagewadi
Rohini.Bagewadi@BSWHealth.org

Intermountain
Murray, Utah 84107
Contact:
Shanelle Cripps
801-507-4732
shanelle.cripps@imail.org

University of Utah
Salt Lake City, Utah 84132
Contact:
Ainsley Huffman
801-587-2093
ainsley.huffman@hsc.utah.edu

VA Salt Lake City Healthcare System
Salt Lake City, Utah 84148
Contact:
Silvia Padilla
silvia.padilla@va.gov

VA Madison Healthcare System
Madison, Wisconsin 53705
Contact:
Karen Lazar
karen.lazar@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
mberendt@mcw.edu

Milwaukee VA Medical Center
Milwaukee, Wisconsin 53295
Contact:
Sage Coles-Dogan
sage.coles-dogan@va.gov

VA Carribbean Healthcare
San Juan, Puerto Rico 00921
Contact:
Sara Fuentes-Medina
sara.fuentes-medina@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 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. Each site 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. 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 combination of central and distributed research teams. This includes a call center as well as a nationwide system of decentralized research staff trained on the protocol able to meet the patient in their home or other desired location. 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.