Health TrialsbyHealthPanel

Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults

ConditionsCognitive Impairment, MildDementiaCardiovascular Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age75+
SponsorDuke University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Community-dwelling adults

Age ≥75 years

English or Spanish as primary language

Able to provide a trusted contact

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 40 Mg Oral Tablet

    Drug

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

  • Placebo oral tablet

    Drug

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

Treatment groups

20,000 Participants
are divided into 2 treatment groups
Group A: atorvastatin 40mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients without diagnosis of new dementia

Number of patients without diagnosis of new dementia in each group (placebo vs. atorvastatin)

Time frame
4 years
2

Number of patients without of persistent disability

Number of patients without chronic disability in each group

Time frame
4 years

Secondary outcomes

1

Cardiovascular mortality measured as a composite of CV death, hospitalization for myocardial infarction/unstable angina, heart failure, stroke/TIA, or coronary revascularization

Cardiovascular mortality is measured by a composite measure of multiple CV conditions.

Time frame
4 years
2

Cognitive disability as measured as a composite of MCI or probable dementia

Cognitive disability is measured by a composite of having mild cognitive impairment or probable dementia.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Wake Forest University Health Sciences

Collaborator

Source ClinicalTrials.gov
Apply now