Purpose

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.

Category

IRB Number
20200339HU
NCT Number
NCT04262206
Sponsor
Duke University -



Study Contact

Principal Investigator
Sara Espinoza

Daisy Castillo
210-617-5311
castillod5@uthscsa.edu

Alice Conde
210-617-5300
condea@uthscsa.edu



Eligibility

Eligible Ages
Over 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized 1:1 atorvastatin 40mg vs. placebo
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)
Condition
  • Cognitive Impairment, Mild
  • Dementia
  • Cardiovascular Diseases

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    atorvastatin 40mg

    		40mg atorvastatin po qd from consent to study end
  • Drug: Atorvastatin 40 Mg Oral Tablet

    To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

    Other names:

    • Lipitor

    • Placebo Comparator

    Placebo

    		matching placebo po qd from consent to study end
  • Drug: Placebo oral tablet

    To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

    •