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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262206
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : September 11, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment, Mild Dementia Cardiovascular Diseases Drug: Atorvastatin 40 Mg Oral Tablet Drug: Placebo oral tablet Phase 4

Detailed Description:

PREVENTABLE will randomly assign atorvastatin 40 mg daily or matching placebo daily to 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. Each site 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. 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 combination of central and distributed research teams. This includes a call center as well as a nationwide system of decentralized research staff trained on the protocol able to meet the patient in their home or other desired location. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1 atorvastatin 40mg vs. placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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 Name: 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,




Primary Outcome Measures :
  1. Number of patients without diagnosis of new dementia [ Time Frame: 4 years ]
    Number of patients without diagnosis of new dementia in each group (placebo vs. atorvastatin)

  2. Number of patients without of persistent disability [ Time Frame: 4 years ]
    Number of patients without chronic disability in each group


Secondary Outcome Measures :
  1. Cardiovascular mortality measured as a composite of CV death, hospitalization for myocardial infarction/unstable angina, heart failure, stroke/TIA, or coronary revascularization [ Time Frame: 4 years ]
    Cardiovascular mortality is measured by a composite measure of multiple CV conditions.

  2. Cognitive disability as measured as a composite of MCI or probable dementia [ Time Frame: 4 years ]
    Cognitive disability is measured by a composite of having mild cognitive impairment or probable dementia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262206


Contacts
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Contact: Samantha Wrenn 919-907-8961 samantha.wrenn@duke.edu
Contact: Mary Ann Sellers 9196688544 maryann.sellers@duke.edu

Locations
Show Show 86 study locations
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04262206    
Other Study ID Numbers: Pro00103844
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
statin
older adults
Additional relevant MeSH terms:
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Cardiovascular Diseases
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors