Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
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
- Cognitive Impairment, Mild
- Dementia
- Cardiovascular Diseases
Eligibility
- Eligible Ages
- Over 75 Years
- Eligible Sex
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental atorvastatin 40mg |
40mg atorvastatin po qd from consent to study end |
|
|
Placebo Comparator Placebo |
matching placebo po qd from consent to study end |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35205
Birmingham 4049979, Alabama 4829764 35233
Tucson 5318313, Arizona 5551752 85723
Little Rock 4119403, Arkansas 4099753 72114
Little Rock 4119403, Arkansas 4099753 72204
Fresno 5350937, California 5332921 93703
Long Beach 5367929, California 5332921 90822
Los Angeles 5368361, California 5332921 90073
San Diego 5391811, California 5332921 92161
New Haven 4839366, Connecticut 4831725 06520
West Haven 4845419, Connecticut 4831725 006111
Study Coordinator
203-932-5711
Bay Pines 4146855, Florida 4155751 33744
Gainesville 4156404, Florida 4155751 32608
Gainesville 4156404, Florida 4155751 32610
Jacksonville 4160021, Florida 4155751 32608
Miami 4164138, Florida 4155751 33125
Miami 4164138, Florida 4155751 33136
Atlanta 4180439, Georgia 4197000 30033
Atlanta 4180439, Georgia 4197000 30322
Chicago 4887398, Illinois 4896861 60208
Chicago 4887398, Illinois 4896861 60608
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60637
Hines 4896005, Illinois 4896861 60141
North Chicago 4903862, Illinois 4896861 60064
Indianapolis 4259418, Indiana 4921868 46202
Iowa City 4862034, Iowa 4862182 52242
Kansas City 4273837, Kansas 4273857 64128
Kansas City 4273837, Kansas 4273857 66160
Louisville 4299276, Kentucky 6254925 40206
New Orleans 4335045, Louisiana 4331987 70121
Togus 4980872, Maine 4971068 04330
Baltimore 4347778, Maryland 4361885 21287
Boston 4930956, Massachusetts 6254926 002130
Ann Arbor 4984247, Michigan 5001836 48105
Ann Arbor 4984247, Michigan 5001836 48109
Duluth 5024719, Minnesota 5037779 55805
Rochester 5043473, Minnesota 5037779 55905
Jackson 4431410, Mississippi 4436296 39216
Jackson 4431410, Mississippi 4436296 39216
Columbia 4381982, Missouri 4398678 65212
St Louis 4407066, Missouri 4398678 63106
St Louis 4407066, Missouri 4398678 63130
Omaha 5074472, Nebraska 5073708 67105
Omaha 5074472, Nebraska 5073708 68105
Manhasset 5125766, New York 5128638 11030
New York 5128581, New York 5128638 10021
The Bronx 5110266, New York 5128638 10461
Asheville 4453066, North Carolina 4482348 28805
Chapel Hill 4460162, North Carolina 4482348 27599
Charlotte 4460243, North Carolina 4482348 28207
Durham 4464368, North Carolina 4482348 27701
Khaula Baloch
Durham 4464368, North Carolina 4482348 27705
Durham 4464368, North Carolina 4482348 27710
Kannapolis 4474040, North Carolina 4482348 28081
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
Cincinnati 4508722, Ohio 5165418 45220
Cleveland 5150529, Ohio 5165418 44106
Columbus 4509177, Ohio 5165418 43210
Dayton 4509884, Ohio 5165418 45428
Pittsburgh 5206379, Pennsylvania 6254927 15213
Providence 5224151, Rhode Island 5224323 002908
Charleston 4574324, South Carolina 4597040 29401
Charleston 4574324, South Carolina 4597040 29403
Columbia 4575352, South Carolina 4597040 29209
Memphis 4641239, Tennessee 4662168 38104
Nashville 4644585, Tennessee 4662168 37208
Nashville 4644585, Tennessee 4662168 37212
Nashville 4644585, Tennessee 4662168 37212
Dallas 4684888, Texas 4736286 75210
Dallas 4684888, Texas 4736286 75216
Dallas 4684888, Texas 4736286 75390
Edinburg 4688275, Texas 4736286 78539
Houston 4699066, Texas 4736286 77204
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Murray 5778755, Utah 5549030 84107
Salt Lake City 5780993, Utah 5549030 84148
Richmond 4781708, Virginia 6254928 23219
Eau Claire 5251436, Wisconsin 5279468 54703
La Crosse 5258957, Wisconsin 5279468 54601
Madison 5261457, Wisconsin 5279468 53705
Marshfield 5261969, Wisconsin 5279468 54449
Milwaukee 5263045, Wisconsin 5279468 53295
Milwaukee 5263045, Wisconsin 5279468 53295
San Juan 4568127, Puerto Rico 00921
More Details
- NCT ID
- NCT04262206
- Status
- Recruiting
- Sponsor
- Duke University
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.