Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Lay Description
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
- Heart, Vascular and Blood
- Aging and Geriatric
- Dementia / Alzheimers
- IRB Number
- 20200339HU
- NCT Number
- NCT04262206
- Open to Enrollment
- Not set
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
Arm Groups
Study Contact
Regulatory Point of Contact
Alice Conde
(210) 617-5190
condea@uthscsa.edu
Regulatory Point of Contact
Tiffany Cortes
(210) 450-8998
cortest@uthscsa.edu
Regulatory Point of Contact
Sara Espinoza
(210) 617-5197
espinozas2@uthscsa.edu
Regulatory Point of Contact
Sandra Idar
(210) 450-0568
idars@uthscsa.edu
Regulatory Point of Contact
Nicolas Musi
(210) 562-6140
musi@uthscsa.edu
Local Recruitment Point of Contact
Alice Conde
(210) 617-5190
condea@uthscsa.edu
Local Recruitment Point of Contact
Sara Espinoza
(210) 617-5197
espinozas2@uthscsa.edu
Local Recruitment Point of Contact
Sandra Idar
(210) 450-0568
idars@uthscsa.edu
Principal Investigator
Nicolas Musi