Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
Duke University
20,000 participants
Sep 1, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Community-dwelling adults
- Age ≥75 years
- English or Spanish as primary language
- Able to provide a trusted contact
Exclusion Criteria10
- 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
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Interventions
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
Locations(103)
View Full Details on ClinicalTrials.gov
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NCT04262206