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Recruiting Phase 4 NCT04262206

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

Trial Parameters

Condition Cognitive Impairment, Mild
Sponsor Duke University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 20,000
Sex ALL
Min Age 75 Years
Max Age N/A
Start Date 2020-09-01
Completion 2026-12-31
Interventions
Atorvastatin 40 Mg Oral TabletPlacebo oral tablet

Brief 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.

Eligibility Criteria

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

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