Pragmatic Evaluation of Events And Benefits of Lipid-lowering in older Adults (PREVENTABLE)

About this Study

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.

Sponsor Protocol ID:PREVENTABLE
IRB Number:2020V0312
Actively Enrolling
Phase 4
January 15, 2021
Eligibility Criteria
75 years old
Both Male and Female

Inclusion Criteria
  • Community-dwelling adults
  • Age 75 years or older

Exclusion Criteria
  • Clinically evident CVD, defined as prior MI, prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin as determined by their clinician.
  • Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure without clinically evident cardiovascular disease is not an exclusion)
  • Dementia (clinically evident and/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)
  • Severe visual impairment (preventing cognitive testing)
  • 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