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

January 17, 2024 updated by: Duke University

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Recruiting
        • VA Carribbean Healthcare
        • Principal Investigator:
          • William Rodriguez-Cintron
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Birmingham VA
        • Principal Investigator:
          • Alayne Markland
        • Contact:
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Tapan Mehta, MD
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Health Care System - Tucson
        • Principal Investigator:
          • Mark Liu
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72114
        • Recruiting
        • Little Rock VA Medical Center
        • Principal Investigator:
          • Dennis Sullivan
        • Contact:
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
        • Principal Investigator:
          • Gohar Azhar, MD
    • California
      • Fresno, California, United States, 93703
        • Recruiting
        • Fresno VA Medical Center
        • Principal Investigator:
          • Sudeshna Kundu
        • Contact:
      • Long Beach, California, United States, 90822
        • Recruiting
        • Long Beach VA Medical Center
        • Principal Investigator:
          • Kenny Vu
        • Contact:
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Ebinger
      • Los Angeles, California, United States, 90073
        • Recruiting
        • VA Greater Los Angeles
        • Principal Investigator:
          • Cathy Lee
        • Contact:
      • Palo Alto, California, United States, 94550
        • Withdrawn
        • VA Palo Alto Healthcare System
      • San Diego, California, United States, 92161
        • Recruiting
        • VA San Diego Medical Center
        • Principal Investigator:
          • William Penny
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Thomas Gill
        • Contact:
      • West Haven, Connecticut, United States, 006111
        • Recruiting
        • VA Connecticut Healthcare System
        • Principal Investigator:
          • Brian Malm
        • Contact:
          • Study Coordinator
          • Phone Number: 7464 203-932-5711
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines VA
        • Principal Investigator:
          • Dennis Hall
        • Contact:
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Stephen Anton
        • Contact:
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • Gainesville VA Medical Center
        • Principal Investigator:
          • Sriram Peruvemba
        • Contact:
      • Jacksonville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Stephen Anton
        • Contact:
      • Miami, Florida, United States, 33125
        • Recruiting
        • Miami VA Medical Center
        • Principal Investigator:
          • Leonardo Tamnariz
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Olveen Carrasquillo
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Ambar Kulshreshtha, MD
      • Atlanta, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Principal Investigator:
          • Elisabeth Vaughan
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Raj Shah
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60608
        • Recruiting
        • University of Illinois at Chicago
        • Principal Investigator:
          • Howard Gordon
        • Contact:
      • Chicago, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Jeff Linder
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Chicago VA Medical Center/Jesse Brown VA
      • Hines, Illinois, United States, 60141
        • Recruiting
        • Hines VA Medical Center
        • Contact:
        • Principal Investigator:
          • Holly Kramer
      • North Chicago, Illinois, United States, 60064
        • Recruiting
        • North Chicago VA Medical Center
        • Principal Investigator:
          • Raul Gazmuri
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indianapolis VA Medical Center
        • Principal Investigator:
          • James Walsh
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Healthcare
        • Principal Investigator:
          • Michael Ernst
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Kristin Grdinovac
      • Kansas City, Kansas, United States, 64128
        • Recruiting
        • Kansas City VA Medical Center
        • Contact:
        • Principal Investigator:
          • Vikas Singh
      • Topeka, Kansas, United States, 66622
        • Not yet recruiting
        • VA Eastern Kansas Healthcare System
        • Contact:
        • Principal Investigator:
          • Alexander Hallock
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Recruiting
        • Louisville VA Medical Center
        • Principal Investigator:
          • Sathya Krishnasamy
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Lydia Bazzano
        • Sub-Investigator:
          • Mark Effron
      • New Orleans, Louisiana, United States, 70112
        • Completed
        • University Medical Center
    • Maine
      • Togus, Maine, United States, 04330
        • Recruiting
        • Maine VA Health Care System
        • Contact:
        • Principal Investigator:
          • Marie Albert
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Daniel Ford
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 002130
        • Recruiting
        • VA Boston Healthcare System
        • Principal Investigator:
          • Ariela Orkaby
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Pearl Lee
        • Contact:
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • VA Ann Arbor Healthcare System
        • Principal Investigator:
          • Pearl Lee
        • Contact:
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health
        • Principal Investigator:
          • Catherine Benzinger
        • Contact:
      • Minneapolis, Minnesota, United States, 55407
        • Active, not recruiting
        • Allina Health
      • Minneapolis, Minnesota, United States, 55417
        • Withdrawn
        • Minneapolis VA Health Care System
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Alanna Chamberlain
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Michael Hall
        • Contact:
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • VA Medical Center Jackson
        • Principal Investigator:
          • Kent Kirchner
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Health System
        • Principal Investigator:
          • Kristin Hahn-Cover
        • Contact:
      • Saint Louis, Missouri, United States, 63106
        • Recruiting
        • St. Louis VA Medical Center
        • Principal Investigator:
          • Jaifu Ou
        • Sub-Investigator:
          • Michael Kraujalis
        • Contact:
      • Saint Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University in St. Louis
        • Contact:
        • Principal Investigator:
          • Ellen Binder, MD
    • Nebraska
      • Omaha, Nebraska, United States, 67105
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Alfred Fisher
        • Contact:
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • Omaha VA Medical Center
        • Principal Investigator:
          • Alfred Fisher
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89502
        • Withdrawn
        • Reno VA/Sierra Nevada Health Care
    • New York
      • Bronx, New York, United States, 10461
      • Bronx, New York, United States, 10468
        • Withdrawn
        • Bronx VA Medical Center
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Joseph Conigliaro
      • Montrose, New York, United States, 10548
        • Withdrawn
        • VA Hudson Valley Healthcare System
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical College
        • Principal Investigator:
          • Parag Goyal
        • Contact:
      • New York, New York, United States, 10010
        • Not yet recruiting
        • VA New York Harbor Healthcare System
        • Contact:
        • Principal Investigator:
          • Natarajan Sundar
    • North Carolina
      • Asheville, North Carolina, United States, 28805
        • Recruiting
        • Asheville VA-Charles George VA Medical Center
        • Principal Investigator:
          • Brian Peek
        • Contact:
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • David Lynch
      • Charlotte, North Carolina, United States, 28207
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Ranee Chatterjee Montgomery
        • Contact:
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Medical Center
        • Principal Investigator:
          • Kenneth Schmader
        • Contact:
      • Durham, North Carolina, United States, 27701
        • Recruiting
        • PREVENTABLE Tele-Site
        • Contact:
          • Khaula Baloch
        • Principal Investigator:
          • Kristin Newby
      • Kannapolis, North Carolina, United States, 28081
        • Recruiting
        • Duke University - Kannapolis
        • Contact:
        • Principal Investigator:
          • Ranee Chatterjee
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Hospital-Cardiology
        • Principal Investigator:
          • Michael Shapiro
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Hospital - Geriatrics
        • Contact:
        • Principal Investigator:
          • Ezequiel Zamora
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • Cincinnati VA Medical Center
        • Principal Investigator:
          • Jack Rubinstein
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
        • Principal Investigator:
          • Goutham Rao
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Seuli Brill
      • Dayton, Ohio, United States, 45428
        • Recruiting
        • Dayton VA Medical Center
        • Principal Investigator:
          • Ankur Gupta
        • Contact:
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Elizabeth Eckstrom
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Christopher Chambers
      • Philadelphia, Pennsylvania, United States, 19104
        • Withdrawn
        • Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Principal Investigator:
          • Daniel Forman
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 002908
        • Recruiting
        • Providence VA Medical Center
        • Principal Investigator:
          • Gaurav Choudhary
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Charleston VA Medical Center
        • Principal Investigator:
          • Fernandez Jyotika
        • Contact:
      • Charleston, South Carolina, United States, 29403
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Leslie Lenert
      • Columbia, South Carolina, United States, 29209
        • Recruiting
        • Columbia VA Health Care/Dorn VA Medical Center
        • Principal Investigator:
          • Andres Munoz
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • VA Medical Center Memphis
        • Principal Investigator:
          • Richard Childress
        • Contact:
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Amanda Mixon
        • Contact:
      • Nashville, Tennessee, United States, 37208
        • Recruiting
        • Meharry Medical College
        • Principal Investigator:
          • Richmond Akatue
        • Sub-Investigator:
          • Rajbir Singh
        • Contact:
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Nashville VA Medical Center
        • Principal Investigator:
          • Christianne Roumie
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216
        • Recruiting
        • Dallas VA Medical Center
        • Principal Investigator:
          • Kyaw Soe
        • Contact:
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center Dallas
        • Contact:
        • Principal Investigator:
          • Craig Rubin
      • Dallas, Texas, United States, 75210
        • Recruiting
        • Baylor Scott and White Medical Center
        • Contact:
        • Principal Investigator:
          • Katherine Sanchez
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • Doctors Hospital at Renaissance
        • Contact:
        • Principal Investigator:
          • Juan Salazar, MD
        • Sub-Investigator:
          • Adrienne Casciato, MD
      • Houston, Texas, United States, 77204
        • Recruiting
        • University of Texas at Houston
        • Contact:
        • Principal Investigator:
          • Jessica Lee, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Principal Investigator:
          • Nicolas Musi
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • San Antonio VA Medical Center
        • Contact:
        • Principal Investigator:
          • Sara Espinoza
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain
        • Contact:
        • Principal Investigator:
          • Kirk Knowlton
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • VA Salt Lake City Healthcare System
        • Principal Investigator:
          • Paul Eleazer
        • Contact:
      • Salt Lake City, Utah, United States, 84132
        • Active, not recruiting
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Richmond VA
        • Contact:
        • Principal Investigator:
          • Michael Godschalk
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Withdrawn
        • Clarksburg VA Medical Center
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Recruiting
        • Mayo Clinic Health Systems - NW Wisconsin
        • Contact:
        • Principal Investigator:
          • Steven Rosas
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Mayo Clinic Health System SW Wisconsin
        • Contact:
        • Principal Investigator:
          • Thomas Loepfe
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • VA Madison Healthcare System
        • Principal Investigator:
          • Cynthia Carlsson
        • Contact:
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53295
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Jake Decker
      • Milwaukee, Wisconsin, United States, 53295
        • Recruiting
        • Milwaukee VA Medical Center
        • Principal Investigator:
          • Jeff Whittle
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 (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)
  • 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
  • Long-term use of daily colchicine, verapamil at any dose, or diltiazem at a dose >240mg/day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 years
Number of patients without of persistent disability
Time Frame: 4 years
Number of patients without chronic disability in each group
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Wake Forest University Health Sciences

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 Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103844
  • 1U19AG065188-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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