PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
Duke University
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 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 si…
Eligibility
- Age range
- 75+ years
- Sex
- All
- 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) * De…
Interventions
- DrugAtorvastatin 40 Mg Oral Tablet
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
- DrugPlacebo oral tablet
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
Locations (103)
- University of Alabama at BirminghamBirmingham, Alabama
- Birmingham VABirmingham, Alabama
- Southern Arizona VA Health Care System - TucsonTucson, Arizona
- Little Rock VA Medical CenterLittle Rock, Arkansas
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Fresno VA Medical CenterFresno, California