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Pragmatic Evaluation of Event...

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

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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PREVENTABLE will randomly assign atorvastatin 40 mg daily or matching placebo daily to approximately 20,000 community-dwelling adults 75 years of age or older without clinically evident cardiovascular disease, significant disability, or dementia, and follow them for up to 5 years (estimated median of 3.8 years). The study will enroll participants from approximately 100 US sites. Community engagement efforts will leverage community groups and practices as collaborators for recruitment. We plan to partner with participants, caregivers, and clinicians in all aspects of the study. The enrolling sites are non-VA and VA sites. To assist in recruitment, sites will apply a study-specific cohort identification algorithm to their electronic health record to create a list of eligible participants based on study inclusion and exclusion criteria. The cohort identification will exclude individuals with clinically evident cardiovascular disease, significant disability, or dementia and other exclusions obtainable from data queries to define a potential cohort. Additionally, the PREVENTABLE CCC will provide a centralized support team to assist with recruitment and retention efforts. This includes mass mailings and/or phone calls to potential participants and a toll-free number for potential participants to call for information and pre-screening. Interested and potentially eligible participants will be referred to an enrolling site near them, if applicable, otherwise, they will be referred to the PREVENTABLE Telesite which is capable of enrolling English and Spanish-speaking participants across the U.S. remotely. Sites will screen potential participants to confirm eligibility and consent and randomize those interested in joining the study. Specifically related to dementia, the qualifying exclusion is a clinical diagnosis in the chart or clinician's assessment that dementia may be present.

Sites will enter contact information, mailing address for study drug, demographic information, height, weight, statin history (if any), Social Security Number, and aspects of the medical history not obtainable from EHR. In addition, a Short Physical Performance Battery (SPPB) and Activities of Daily Living (ADL) screen will be site-performed at baseline. SPPB will provide an objective assessment of function for understanding frailty and physical function of the enrolled population. Baseline lipid panel (core lab) and biospecimen samples will be obtained using the same blood draw for 20cc of blood. Blinded lipid testing will be performed at baseline on all participants (n=20,000) and repeated at 3 months in a random subset (n=2,000). Lipid panels will be sent to the PREVENTABLE Core Lab to maintain study blind. Future testing of lipid panels during routine clinical care will be actively discouraged, but other laboratory testing as indicated by clinical care is permitted. Sites will have the option for telehealth enrollment. Baseline SPPB and Biorepository Labs are not required, but encouraged.

As part of the study operations, with the rationale of providing patient centricity, ease of participation, and access for vulnerable and at risk participants, follow up will be performed by a central call center. The baseline and annual assessments performed centrally will include a phone screen for cognitive function (TICS-M) and physical function (Patient-reported Outcome Measurement Information System-Physical Function \[PROMIS-PF\]). After year 1, if baseline calls indicated by crossing pre-specified cutpoints, in-person assessments will be completed by trained and certified research staff at a mutually agreed upon time and a standardized interview of a knowledgeable informant. Cardiovascular event ascertainment will be via a systematic approach to data curation from the EHR, Medicare, and National Death Index. For convenience and compliance, the study pharmacy will mail a supply of study drug, sufficient for 90 days, directly to participants. This will start immediately after randomization and continue as long as the participant is on study drug.

Conditions

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Cognitive Impairment, Mild Dementia Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized 1:1 atorvastatin 40mg vs. placebo

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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atorvastatin 40mg

40mg atorvastatin po qd from consent to study end

Group Type EXPERIMENTAL

Atorvastatin 40 Mg Oral Tablet

Intervention Type DRUG

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

Placebo

matching placebo po qd from consent to study end

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

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

Interventions

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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,

Intervention Type DRUG

Placebo oral tablet

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

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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Inclusion Criteria

* Community-dwelling adults
* Age ≥75 years
* English or Spanish as primary language
* Able to provide a trusted contact

Exclusion Criteria

* 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)
* Severe hearing impairment (preventing phone follow up)
* Unable to talk (preventing phone follow up)
* 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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Birmingham VA

Birmingham, Alabama, United States

Site Status RECRUITING

Southern Arizona VA Health Care System - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

Little Rock VA Medical Center

Little Rock, Arkansas, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Fresno VA Medical Center

Fresno, California, United States

Site Status RECRUITING

Long Beach VA Medical Center

Long Beach, California, United States

Site Status RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

VA Greater Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

VA Palo Alto Healthcare System

Palo Alto, California, United States

Site Status WITHDRAWN

VA San Diego Medical Center

San Diego, California, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status RECRUITING

Bay Pines VA

Bay Pines, Florida, United States

Site Status RECRUITING

Gainesville VA Medical Center

Gainesville, Florida, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

University of Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Miami VA Medical Center

Miami, Florida, United States

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status RECRUITING