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

Study acronym: PREVENTABLE
StatusRecruiting
PhasePhase 4
Started2020-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
minor
Study Status, Contacts/Locations v17
Trial sites expanded: 103 → 106 locations
2026-06-02
minor
Study Status, Contacts/Locations v16
Study sitesdetails revised at 5 of 103 sites
2025-11-04
minor
Study Status, Contacts/Locations v15
Study sitescontacts updated at 4 of 103 sites
2025-06-23
minor
Study Status, Contacts/Locations v14
Re-verified, no change to tracked fields
2024-06-14
minor
Study Status, Study Description, Eligibility v13
Primary completion date2026-06-30→2026-12-31
Eligibility criteria-115 characters
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 diseas [...] hone 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 previ [...] ined) 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 description+384 characters
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 w [...] of the study. The enrolling sites are non-VA and VA sites. EachTo siteassist in recruitment, sites will apply a study-specific cohort identification algorithm [...] 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 f [...] [...]
Show 12 earlier versions
2024-01-17
minor
Study Status, Contacts/Locations v12
Study sites96→103
2023-04-11
minor
Study Status, Contacts/Locations v11
Study sites84→96
2022-07-07
minor
Study Status v10
Primary completion date2027-06-30→2026-06-30
Completion date2027-07-31→2026-12-31
2022-03-22
minor
Study Identification, Study Status, Contacts/Locations v9
Primary completion date2026-06→2027-06-30
Completion date2026-07→2027-07-31
Study sites81→84
2021-06-16
minor
Study Status, Eligibility, Contacts/Locations v8
Eligibility criteria+231 characters
Inclusion Criteria: Community-dwelling adults Age ≥75 years English or olderSpanish as primary language Exclusion Criteria: Clinically evident CVD,cardiovascular disease defined as prior myocardial Infarction (MI), prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin as(clinician determined by their clinician.) Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure withoutin the absence of recent hospitalization or clinically evident cardiovascular disease is not an exclusion) Dementia (clini [...] [...]
Study sitesdetails revised at 13 of 81 sites
2021-03-18
minor
Study Status, Contacts/Locations v7
Study sites86→81
2020-11-11
minor
Study Status, Contacts/Locations v6
Study sites85→86
2020-10-05
minor
Study Status, Contacts/Locations v5
Study sites86→85
2020-09-10
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-09→confirmed 2020-09-01
Study sites0→86
2020-07-01
minor
Study Status, Study Description, Contacts/Locations v3
Primary completion date2027-04→2026-06
Completion date2027-04→2026-07
Start date2020-08→2020-09
Study description+65 characters
[...] caregivers, and clinicians in all aspects of the study. The siteenrolling issites anare affiliatednon-VA PCORnetand healthVA system or Veterans Administration hospitalsites. Each site will apply a study-specific cohort identificatio [...] ress for study drug, demographic information, height, weight, blood pressure, statin history (if any), Social Security Number, and aspec [...] boratory 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 ratio [...] [...]
2020-03-31
minor
Study Status v2
Re-verified, no change to tracked fields
2020-02-21
minor
Study Status, Study Description, Eligibility v1
Eligibility criteria-17 characters
Inclusion Criteria: Community-dwelling adults (independent living) Age 75 years or older Exclusion Criteria: Clinically evident CVD, defined as prior MI, prior stroke/TIA, prior revascularization procedure, or a secondary preventi [...] lure in the prior 12 months (Note: History of heart failure in the absence of recent prior hospitalization orwithout clinically evident cardiovascular disease is not an exclusi [...] ) Dementia (clinically evident and/or previously diagnosed) SignificantDependence disabilityin any Katz Basic Activities of Daily Living [ADL] (i.e.,with severethe difficultyexception of urinary [...]
Study description-319 characters
[...] g frailty and physical function of the enrolled population. We intend to collect the SPPB again in at least a random subset and preferably in as many participants as feasible to assess physical function changes over time. The number of participants and timing of assessment will be determined pending available resources and described in detail in the Statisti [...] Baseline lipid panel (core lab) and biospecimen samples will [...]
2020-02-07
minor
Original filing
455 trials monitored
See 53 trials at risk
2,117 trials monitored
See 101 trials at risk
912 trials monitored
See 44 trials at risk
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.
Trial Details
NCT Number NCT04262206
Lead Sponsor Duke University
Collaborators: National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI), Wake Forest University Health Sciences
Conditions Cognitive Impairment, Mild, Dementia, Cardiovascular Diseases
Enrollment 20,000 participants
Start Date 2020-09-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-01