RECRUITING
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Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
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:
🦠 Cognitive Impairment, Mild 🦠 Dementia 🦠 Cardiovascular Diseases
🗓️ Study Start (Actual) 1 September 2020
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 20000
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Birmingham, Alabama, United States
📍 Birmingham, Alabama, United States
📍 Tucson, Arizona, United States
📍 Little Rock, Arkansas, United States
📍 Little Rock, Arkansas, United States
📍 Fresno, California, United States
📍 Long Beach, California, United States
📍 Los Angeles, California, United States
📍 Los Angeles, California, United States
📍 Palo Alto, California, United States
📍 San Diego, California, United States
📍 New Haven, Connecticut, United States
📍 West Haven, Connecticut, United States
📍 Bay Pines, Florida, United States
📍 Gainesville, Florida, United States
📍 Gainesville, Florida, United States
📍 Jacksonville, Florida, United States
📍 Miami, Florida, United States
📍 Miami, Florida, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Hines, Illinois, United States
📍 North Chicago, Illinois, United States
📍 Indianapolis, Indiana, United States
📍 Iowa City, Iowa, United States
📍 Kansas City, Kansas, United States
📍 Kansas City, Kansas, United States
📍 Topeka, Kansas, United States
📍 Louisville, Kentucky, United States
📍 New Orleans, Louisiana, United States
📍 New Orleans, Louisiana, United States
📍 Togus, Maine, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Ann Arbor, Michigan, United States
📍 Duluth, Minnesota, United States
📍 Minneapolis, Minnesota, United States
📍 Minneapolis, Minnesota, United States
📍 Rochester, Minnesota, United States
📍 Jackson, Mississippi, United States
📍 Jackson, Mississippi, United States
📍 Columbia, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Omaha, Nebraska, United States
📍 Omaha, Nebraska, United States
📍 Reno, Nevada, United States
📍 Bronx, New York, United States
📍 Bronx, New York, United States
📍 Manhasset, New York, United States
📍 Montrose, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Asheville, North Carolina, United States
📍 Chapel Hill, North Carolina, United States
📍 Charlotte, North Carolina, United States
📍 Durham, North Carolina, United States
📍 Durham, North Carolina, United States
📍 Durham, North Carolina, United States
📍 Kannapolis, North Carolina, United States
📍 Winston-Salem, North Carolina, United States
📍 Winston-Salem, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States
📍 Dayton, Ohio, United States
📍 Portland, Oregon, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Providence, Rhode Island, United States
📍 Charleston, South Carolina, United States
📍 Charleston, South Carolina, United States
📍 Columbia, South Carolina, United States
📍 Memphis, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Dallas, Texas, United States
📍 Dallas, Texas, United States
📍 Dallas, Texas, United States
📍 Edinburg, Texas, United States
📍 Houston, Texas, United States
📍 San Antonio, Texas, United States
📍 San Antonio, Texas, United States
📍 Murray, Utah, United States
📍 Salt Lake City, Utah, United States
📍 Salt Lake City, Utah, United States
📍 Richmond, Virginia, United States
📍 Clarksburg, West Virginia, United States
📍 Eau Claire, Wisconsin, United States
📍 La Crosse, Wisconsin, United States
📍 Madison, Wisconsin, United States
📍 Marshfield, Wisconsin, United States
📍 Milwaukee, Wisconsin, United States
📍 Milwaukee, Wisconsin, United States
📍 San Juan, Puerto Rico
More locations available...

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 75 Years to N/A (OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 February 2020
  • First Submitted that Met QC Criteria 7 February 2020
  • First Posted 10 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024
I'm interested ...!!