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(904) 244-0411

Pragmatic evaluation of events and benefits of Lipid-lowering in older adults (PREVENTABLE)

  • Status
    Accepting Candidates
  • Age
    75 Years - 100 Years
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

The PREVENTABLE trial aims to find out if a drug called atorvastatin (brand name Lipitor) can help older adults 75 years or older live well for longer by preventing dementia, disability, or heart disease. Research participants can be included if they do not have dementia, significant disability that limits their basic everyday activities, or heart disease. Participation in the study may last up to five year. You will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). At your study visit, the study team will also ask a few questions, draw blood, and perform memory, and physical tests. For most of the study duration, the study team will call you on a yearly basis to see how you are doing.

Details

Protocol number CED000000393

Eligibility

Inclusion Criteria

Community-dwelling adults Age ≥75 years English or Spanish as primary language

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 Dementia (clinically evident or previously diagnosed) Dependence in any Katz Basic Activities of Daily Living [ADL] 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 Ineligible to take atorvastatin 40 mg Documented intolerance to statins Active Liver Disease Long-term use of daily colchicine, verapamil at any dose, or diltiazem at a dose >240mg/day.

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.