Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Duke University
- Study ID
- NCT04262206
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Cardiovascular Diseases
- Cognitive Impairment, Mild
- Dementia
Eligibility Criteria
- Sex
- ALL
- Age
- 75 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Atorvastatin 40 Mg Oral Tablet — DRUGTo generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
- Placebo oral tablet — DRUGTo generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
Study Details
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.
Key Dates
- First listed
- Feb 10, 2020
- Start date
- Sep 1, 2020
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: atorvastatin 40mg40mg atorvastatin po qd from consent to study end
- Placebo Comparator: Placebomatching placebo po qd from consent to study end
Primary Outcome Measure
Number of patients without diagnosis of new dementia [ Time Frame: 4 years ]
Central Contacts
- Pamela Monds9196688695
- Beth Harris9196688700
Locations (104)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Birmingham VA | Birmingham | Alabama | 35233 | Elizabeth Jackson (PRINCIPAL_INVESTIGATOR) |
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | Tanja Dudenbostel, MD (PRINCIPAL_INVESTIGATOR) |
| Southern Arizona VA Health Care System - Tucson | Tucson | Arizona | 85723 | Ann Marie Canelas (PRINCIPAL_INVESTIGATOR) |
| Little Rock VA Medical Center | Little Rock | Arkansas | 72114 | Kalpana Padala (PRINCIPAL_INVESTIGATOR) |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72204 | Jeanne Wei, MD (PRINCIPAL_INVESTIGATOR) |
| Fresno VA Medical Center | Fresno | California | 93703 | Sudeshna Kundu (PRINCIPAL_INVESTIGATOR) |
| Long Beach VA Medical Center | Long Beach | California | 90822 | Kenny Vu (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Nicolas Musi, MD (PRINCIPAL_INVESTIGATOR) |
| VA Greater Los Angeles | Los Angeles | California | 90073 | Cathy Lee (PRINCIPAL_INVESTIGATOR) |
| VA Northern California Health Care System | Mather | California | 95655 | Ajay Sood (PRINCIPAL_INVESTIGATOR) |
| VA Palo Alto Healthcare System | Palo Alto | California | 94550 | - |
| VA San Diego Medical Center | San Diego | California | 92161 | William Penny (PRINCIPAL_INVESTIGATOR) |
| Yale University | New Haven | Connecticut | 06520 | Thomas Gill (PRINCIPAL_INVESTIGATOR) |
| VA Connecticut Healthcare System | West Haven | Connecticut | 006111 | Study Coordinator 203-932-5711 Brian Malm (PRINCIPAL_INVESTIGATOR) |
| Bay Pines VA | Bay Pines | Florida | 33744 | Manjunath Harlapur (PRINCIPAL_INVESTIGATOR) |
| Gainesville VA Medical Center | Gainesville | Florida | 32608 | Sriram Peruvemba (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32610 | Stephen Anton (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Jacksonville | Florida | 32608 | Stephen Anton (PRINCIPAL_INVESTIGATOR) |
| Miami VA Medical Center | Miami | Florida | 33125 | - |
| University of Miami | Miami | Florida | 33136 | Olveen Carrasquillo (PRINCIPAL_INVESTIGATOR) |
| Atlanta VA Medical Center | Atlanta | Georgia | 30033 | Camille Vaughan (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30322 | Ambar Kulshreshtha, MD (PRINCIPAL_INVESTIGATOR) |
| Chicago VA Medical Center/Jesse Brown VA | Chicago | Illinois | 60612 | Howard S Gordon (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60208 | Jeff Linder (PRINCIPAL_INVESTIGATOR) |
| Rush University Medical Center | Chicago | Illinois | 60612 | Raj Shah (PRINCIPAL_INVESTIGATOR) |
| University of Chicago | Chicago | Illinois | 60637 | Tamar Polonsky (PRINCIPAL_INVESTIGATOR) |
| University of Illinois at Chicago | Chicago | Illinois | 60608 | Howard Gordon (PRINCIPAL_INVESTIGATOR) |
| Hines VA Medical Center | Hines | Illinois | 60141 | Holly Kramer (PRINCIPAL_INVESTIGATOR) |
| North Chicago VA Medical Center | North Chicago | Illinois | 60064 | Raul J Gazmuri (PRINCIPAL_INVESTIGATOR) |
| Indianapolis VA Medical Center | Indianapolis | Indiana | 46202 | James Walsh (PRINCIPAL_INVESTIGATOR) Gulminay Mosin (PRINCIPAL_INVESTIGATOR) |
| University of Iowa Healthcare | Iowa City | Iowa | 52242 | Michael Ernst (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Kristin Grdinovac (PRINCIPAL_INVESTIGATOR) |
| VA Eastern Kansas Healthcare System | Topeka | Kansas | 66622 | Alexander Hallock (PRINCIPAL_INVESTIGATOR) |
| Louisville VA Medical Center | Louisville | Kentucky | 40206 | Sathya Krishnasamy (PRINCIPAL_INVESTIGATOR) |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | Lydia Bazzano (PRINCIPAL_INVESTIGATOR) Mark Effron (SUB_INVESTIGATOR) |
| University Medical Center | New Orleans | Louisiana | 70112 | - |
| Maine VA Health Care System | Togus | Maine | 04330 | David Duchin (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins University | Baltimore | Maryland | 21287 | Daniel Ford (PRINCIPAL_INVESTIGATOR) |
| VA Boston Healthcare System | Boston | Massachusetts | 02130 | Ariela Orkaby (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Pearl Lee (PRINCIPAL_INVESTIGATOR) |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | Pearl Lee (PRINCIPAL_INVESTIGATOR) |
| Essentia Health | Duluth | Minnesota | 55805 | Catherine Benzinger (PRINCIPAL_INVESTIGATOR) |
| Allina Health | Minneapolis | Minnesota | 55407 | - |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | Alanna Chamberlain (PRINCIPAL_INVESTIGATOR) |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | Michael Hall (PRINCIPAL_INVESTIGATOR) |
| VA Medical Center Jackson | Jackson | Mississippi | 39216 | Anita Basu (PRINCIPAL_INVESTIGATOR) |
| University of Missouri Health System | Columbia | Missouri | 65212 | Kristin Hahn-Cover (PRINCIPAL_INVESTIGATOR) |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | Vikas Singh (PRINCIPAL_INVESTIGATOR) |
| St. Louis VA Medical Center | St Louis | Missouri | 63106 | Jaifu Ou (PRINCIPAL_INVESTIGATOR) |
| Washington University in St. Louis | St Louis | Missouri | 63130 | Ellen Binder, MD (PRINCIPAL_INVESTIGATOR) |
| Omaha VA Medical Center | Omaha | Nebraska | 68105 | Alfred Fisher (PRINCIPAL_INVESTIGATOR) |
| University of Nebraska Medical Center | Omaha | Nebraska | 67105 | Alfred Fisher (PRINCIPAL_INVESTIGATOR) |
| Reno VA/Sierra Nevada Health Care | Reno | Nevada | 89502 | - |
| Northwell Health | Manhasset | New York | 11030 | Joseph Conigliaro (PRINCIPAL_INVESTIGATOR) |
| VA Hudson Valley Healthcare System | Montrose | New York | 10548 | - |
| VA New York Harbor Healthcare System | New York | New York | 10010 | Sundar Natarajan (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medical College | New York | New York | 10021 | Parag Goyal (PRINCIPAL_INVESTIGATOR) |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | Carlos Rodriguez (PRINCIPAL_INVESTIGATOR) |
| Bronx VA Medical Center | The Bronx | New York | 10468 | Matthew Augustine (PRINCIPAL_INVESTIGATOR) |
| Asheville VA-Charles George VA Medical Center | Asheville | North Carolina | 28805 | Brian Peek (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | David Lynch (PRINCIPAL_INVESTIGATOR) |
| Atrium Health | Charlotte | North Carolina | 28207 | Lindsay Shade (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27710 | Ranee Chatterjee Montgomery (PRINCIPAL_INVESTIGATOR) |
| Durham VA Medical Center | Durham | North Carolina | 27705 | - |
| PREVENTABLE Tele-Site | Durham | North Carolina | 27701 | Khaula Baloch Kristin Newby (PRINCIPAL_INVESTIGATOR) |
| Duke University - Kannapolis | Kannapolis | North Carolina | 28081 | Ranee Chatterjee (PRINCIPAL_INVESTIGATOR) |
| Wake Forest Baptist Hospital-Cardiology | Winston-Salem | North Carolina | 27157 | Michael Shapiro (PRINCIPAL_INVESTIGATOR) |
| Wake Forest Hospital - Geriatrics | Winston-Salem | North Carolina | 27157 | Ezequiel Zamora (PRINCIPAL_INVESTIGATOR) |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | Jack Rubinstein (PRINCIPAL_INVESTIGATOR) |
| Case Western Reserve University | Cleveland | Ohio | 44106 | Goutham Rao (PRINCIPAL_INVESTIGATOR) |
| Ohio State University | Columbus | Ohio | 43210 | Seuli Brill (PRINCIPAL_INVESTIGATOR) |
| Dayton VA Medical Center | Dayton | Ohio | 45428 | Ankur Gupta (PRINCIPAL_INVESTIGATOR) |
| Oregon Health and Science University | Portland | Oregon | 97239 | Elizabeth Eckstrom (PRINCIPAL_INVESTIGATOR) |
| Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA | Philadelphia | Pennsylvania | 19104 | - |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Christopher Chambers (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Daniel Forman (PRINCIPAL_INVESTIGATOR) |
| Providence VA Medical Center | Providence | Rhode Island | 002908 | Gaurav Choudhary (PRINCIPAL_INVESTIGATOR) |
| Charleston VA Medical Center | Charleston | South Carolina | 29401 | Fernandes Jyotika (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | Leslie Lenert (PRINCIPAL_INVESTIGATOR) |
| Columbia VA Health Care System/Dorn VA Medical Center | Columbia | South Carolina | 29209 | Andres Munoz (PRINCIPAL_INVESTIGATOR) |
| VA Medical Center Memphis | Memphis | Tennessee | 38104 | - |
| Meharry Medical College | Nashville | Tennessee | 37208 | Richmond Akatue (PRINCIPAL_INVESTIGATOR) Rajbir Singh (SUB_INVESTIGATOR) |
| Nashville VA Medical Center | Nashville | Tennessee | 37212 | Christianne Roumie (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | Amanda Mixon (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott and White Medical Center | Dallas | Texas | 75210 | Katherine Sanchez (PRINCIPAL_INVESTIGATOR) |
| Dallas VA Medical Center | Dallas | Texas | 75216 | Kyaw Soe (PRINCIPAL_INVESTIGATOR) |
| University of Texas Southwestern Medical Center Dallas | Dallas | Texas | 75390 | Craig Rubin (PRINCIPAL_INVESTIGATOR) |
| Doctors Hospital at Renaissance | Edinburg | Texas | 78539 | Juan Salazar, MD (PRINCIPAL_INVESTIGATOR) Adrienne Casciato, MD (SUB_INVESTIGATOR) |
| University of Texas at Houston | Houston | Texas | 77204 | Jessica Lee, MD (PRINCIPAL_INVESTIGATOR) |
| San Antonio VA Medical Center | San Antonio | Texas | 78229 | Marcos Restrepo (PRINCIPAL_INVESTIGATOR) |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | Nicolas Musi (PRINCIPAL_INVESTIGATOR) |
| Intermountain | Murray | Utah | 84107 | Kirk Knowlton (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84132 | - |
| VA Salt Lake City Healthcare System | Salt Lake City | Utah | 84148 | Amy Cowan (PRINCIPAL_INVESTIGATOR) |
| McGuire VA Medical Center | Richmond | Virginia | 23219 | Michael Godschalk (PRINCIPAL_INVESTIGATOR) |
| Clarksburg VA Medical Center | Clarksburg | West Virginia | 26301 | - |
| Mayo Clinic Health Systems - NW Wisconsin | Eau Claire | Wisconsin | 54703 | Steven Rosas (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Health System SW Wisconsin | La Crosse | Wisconsin | 54601 | Thomas Loepfe (PRINCIPAL_INVESTIGATOR) |
| Madison VA Medical Center | Madison | Wisconsin | 53705 | Cynthia Carlsson (PRINCIPAL_INVESTIGATOR) |
| University of Wisconsin at Madison | Madison | Wisconsin | 53792 | Cynthia Carlsson, MD (PRINCIPAL_INVESTIGATOR) |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | Jeffrey Vanwormer (PRINCIPAL_INVESTIGATOR) |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53295 | Jake Decker (PRINCIPAL_INVESTIGATOR) |
| Milwaukee VA Medical Center | Milwaukee | Wisconsin | 53295 | Jeffrey Whittle (PRINCIPAL_INVESTIGATOR) |
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