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NCT04262206 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

— PREVENTABLE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04262206
Other study ID # Pro00103844
Secondary ID 1U19AG065188-01
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2026

Study information
Verified date March 2023
Source Duke University
Contact Jennifer Hervey
Phone 919-668-1965
Email jennifer.hervey@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20000
Est. completion date December 31, 2026
Est. primary completion date June 30, 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 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

Related Conditions & MeSH terms

Intervention

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,
• Placebo oral tablet
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

Locations
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

Sponsors (4)
Lead Sponsor Collaborator
Duke University National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), Wake Forest University Health Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
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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