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

NCT04262206 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

Interventions

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,

DRUG

Placebo oral tablet

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Duke University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262206 on ClinicalTrials.gov