Cardiovascular Diseases Clinical Trial
— PREVENTABLEOfficial title:
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
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.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 75 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | VA Carribbean Healthcare | San Juan | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | VA Ann Arbor Healthcare System | Ann Arbor | Michigan |
United States | Asheville VA-Charles George VA Medical Center | Asheville | North Carolina |
United States | Atlanta VA Medical Center | Atlanta | Georgia |
United States | Emory University | Atlanta | Georgia |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Bay Pines VA | Bay Pines | Florida |
United States | Birmingham VA | Birmingham | Alabama |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | VA Boston Healthcare System | Boston | Massachusetts |
United States | Albert Einstein College of Medicine | Bronx | New York |
United States | Bronx VA Medical Center | Bronx | New York |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Charleston VA Medical Center | Charleston | South Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Atrium Health | Charlotte | North Carolina |
United States | Chicago VA Medical Center/Jesse Brown VA | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Cincinnati VA Medical Center | Cincinnati | Ohio |
United States | Clarksburg VA Medical Center | Clarksburg | West Virginia |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Columbia VA Health Care/Dorn VA Medical Center | Columbia | South Carolina |
United States | University of Missouri Health System | Columbia | Missouri |
United States | Ohio State University | Columbus | Ohio |
United States | Baylor Scott and White Medical Center | Dallas | Texas |
United States | Dallas VA Medical Center | Dallas | Texas |
United States | University of Texas Southwestern Medical Center Dallas | Dallas | Texas |
United States | Dayton VA Medical Center | Dayton | Ohio |
United States | Essentia Health | Duluth | Minnesota |
United States | Duke University | Durham | North Carolina |
United States | Durham VA Medical Center | Durham | North Carolina |
United States | PREVENTABLE Tele-Site | Durham | North Carolina |
United States | Mayo Clinic Health Systems - NW Wisconsin | Eau Claire | Wisconsin |
United States | Doctors Hospital at Renaissance | Edinburg | Texas |
United States | Fresno VA Medical Center | Fresno | California |
United States | Gainesville VA Medical Center | Gainesville | Florida |
United States | University of Florida | Gainesville | Florida |
United States | Hines VA Medical Center | Hines | Illinois |
United States | University of Texas at Houston | Houston | Texas |
United States | Indianapolis VA Medical Center | Indianapolis | Indiana |
United States | University of Iowa Healthcare | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | VA Medical Center Jackson | Jackson | Mississippi |
United States | University of Florida | Jacksonville | Florida |
United States | Duke University - Kannapolis | Kannapolis | North Carolina |
United States | Kansas City VA Medical Center | Kansas City | Kansas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Mayo Clinic Health System SW Wisconsin | La Crosse | Wisconsin |
United States | Little Rock VA Medical Center | Little Rock | Arkansas |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Long Beach VA Medical Center | Long Beach | California |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | VA Greater Los Angeles | Los Angeles | California |
United States | Louisville VA Medical Center | Louisville | Kentucky |
United States | VA Madison Healthcare System | Madison | Wisconsin |
United States | Northwell Health | Manhasset | New York |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | VA Medical Center Memphis | Memphis | Tennessee |
United States | Miami VA Medical Center | Miami | Florida |
United States | University of Miami | Miami | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Milwaukee VA Medical Center | Milwaukee | Wisconsin |
United States | Allina Health | Minneapolis | Minnesota |
United States | Minneapolis VA Health Care System | Minneapolis | Minnesota |
United States | VA Hudson Valley Healthcare System | Montrose | New York |
United States | Intermountain | Murray | Utah |
United States | Meharry Medical College | Nashville | Tennessee |
United States | Nashville VA Medical Center | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | University Medical Center | New Orleans | Louisiana |
United States | VA New York Harbor Healthcare System | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | North Chicago VA Medical Center | North Chicago | Illinois |
United States | Omaha VA Medical Center | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | VA Palo Alto Healthcare System | Palo Alto | California |
United States | Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Providence VA Medical Center | Providence | Rhode Island |
United States | Reno VA/Sierra Nevada Health Care | Reno | Nevada |
United States | Richmond VA | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | St. Louis VA Medical Center | Saint Louis | Missouri |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | University of Utah | Salt Lake City | Utah |
United States | VA Salt Lake City Healthcare System | Salt Lake City | Utah |
United States | San Antonio VA Medical Center | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | VA San Diego Medical Center | San Diego | California |
United States | Maine VA Health Care System | Togus | Maine |
United States | VA Eastern Kansas Healthcare System | Topeka | Kansas |
United States | Southern Arizona VA Health Care System - Tucson | Tucson | Arizona |
United States | VA Connecticut Healthcare System | West Haven | Connecticut |
United States | Wake Forest Baptist Hospital-Cardiology | Winston-Salem | North Carolina |
United States | Wake Forest Hospital - Geriatrics | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), Wake Forest University Health Sciences |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients without diagnosis of new dementia | Number of patients without diagnosis of new dementia in each group (placebo vs. atorvastatin) | 4 years | |
Primary | Number of patients without of persistent disability | Number of patients without chronic disability in each group | 4 years | |
Secondary | Cardiovascular mortality measured as a composite of CV death, hospitalization for myocardial infarction/unstable angina, heart failure, stroke/TIA, or coronary revascularization | Cardiovascular mortality is measured by a composite measure of multiple CV conditions. | 4 years | |
Secondary | Cognitive disability as measured as a composite of MCI or probable dementia | Cognitive disability is measured by a composite of having mild cognitive impairment or probable dementia. | 4 years |
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