Aspirin in Reducing Events in the Elderly (ASPREE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Minneapolis Medical Research Foundation
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01038583
First received: December 21, 2009
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

The ASPREE study will examine whether the potential benefits of low dose aspirin (particularly preventing heart disease, stroke, certain cancers and dementia) outweigh the risks (particularly bleeding) in people over age 65.

ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a disability-free life in healthy participants aged 65 years and above.


Condition Intervention Phase
Functional Disability
Dementia
Heart Disease
Stroke
Cancer
Bleeding
Drug: 100 mg enteric-coated aspirin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Aspirin in Reducing Events in the Elderly

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Fatal and non fatal cardiovascular events including a) coronary heart disease death, b) non-fatal MI, c) fatal and non-fatal stroke and d) any hospitalization for heart failure [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Dementia [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below) [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Physical disability [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Major hemorrhagic events [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 19000
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin
100 mg enteric-coated aspirin
Drug: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo
100 mg enteric-coated placebo

Detailed Description:

Low dose aspirin therapy has been shown to reduce the risk of vascular events, largely in middle-aged people. There is also some evidence of its potential to reduce the rate of intellectual decline and certain types cancers in older participants. However, part of the benefit of aspirin may be offset by adverse effects, such as those related to its potential to cause bleeding.

The balance of risks and benefits of low dose aspirin has not been established in older persons. Previous studies on the effects of aspirin in primary prevention have mainly focused on cardiovascular outcomes. In the elderly, these alone may not be the most appropriate measure of benefit associated with aspirin treatment. Prolonging a life free of functional disability in a healthy aging population would be the most desirable benefit of aspirin as a preventative medicine.

ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a disability-free life in healthy participants aged 65 years and above.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women
  • African American and Hispanic persons age 65 or older
  • Any person from another ethnic minority group age 70 or older
  • Willing and able to provide informed consent, and willing to accept the study requirements

[ASPREE has completed enrollment of Caucasian participants in the US.]

Exclusion Criteria:

  • A history of a diagnosed cardiovascular event
  • A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease
  • A current or recurrent condition with a high risk of major bleeding, ex: cerebral aneurysm
  • Anemia
  • Absolute contraindication or allergy to aspirin
  • Current participation in a clinical trial
  • Current continuous use of aspirin or other anti-platelet drug or anticoagulant for secondary prevention. People with previous use of aspirin for primary prevention may enter the trial, provided they agree to cease existing use of aspirin and understand that they may be subsequently randomly allocated to low dose aspirin or placebo.
  • A systolic blood pressure ≥180 mmHg and / or a diastolic blood pressure ≥105 mmHg
  • A history of dementia
  • Severe difficulty or an inability to perform any one of the 6 Katz ADLs
  • Non-compliance to taking pill
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038583

Contacts
Contact: Nathan J Tessum 612-341-7907 ntessum@bermancenter.org
Contact: Brenda Kirpach 612-341-7922 bkirpach@bermancenter.org

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Cathy Stallings    205-934-7683      
Principal Investigator: Beth Lewis, MD         
United States, California
Palo Alto Medical Foundation Research Institute Recruiting
Palo Alto, California, United States, 94301
Contact: Elsie Wang    650-853-2871      
Principal Investigator: Latha Palaniappan, MD         
United States, District of Columbia
Howard University Recruiting
Washington, District of Columbia, United States, 20060
Contact: Oludolapo Ogunlana    202-865-1973      
Principal Investigator: Thomas Obisesan, MD         
United States, Florida
University of Florida Department of Aging and Geriatrics Recruiting
Gainsville, Florida, United States, 32611
Contact: Emily Chappelle    352-273-5919      
Principal Investigator: Steven Anton, MD         
United States, Georgia
Emory/ Atlanta VAMC Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stephanie Stennett    404-321-6111 ext 7364      
Principal Investigator: Peter Wilson, MD         
Morehouse School of Medicine Recruiting
Atlanta, Georgia, United States, 30310
Contact: Connie Jones    404-752-1133      
Principal Investigator: Pricilla Pema, MD         
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: Darlene Gibson    706-721-4335    dagibson@gru.edu   
Principal Investigator: Daron Ferris, MD         
United States, Illinois
Rush Alzheimer's Disease Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Karen Graham    312-942-6118      
Principal Investigator: Raj Shah, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Michael Ernst    319-384-7756      
Principal Investigator: Michael Ernst, PharmD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66106
Contact: Natalya Stolyar    913-945-7676      
Principal Investigator: Jeffery Burns, MD         
United States, Louisiana
Baton Rouge General Recruiting
Baton Rouge, Louisiana, United States, 70801
Contact: Heidi Millet    225-763-3089    Heidi.Millet@pbrc.edu   
Principal Investigator: Timothy Church, MD         
Mary Bird Perkins Our Lady of the Lake Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Dawn Rachal    225-215-1185    drachal@marybird.com   
Principal Investigator: David Hanson, MD         
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Heidi Millet    225-763-3089      
Principal Investigator: Timothy Church, MD         
Mary Bird Perkins St. Tammany Parish Hospital Recruiting
Covington, Louisiana, United States, 70433
Contact: Julie Nunez       jnunez@marybird.com   
Principal Investigator: Patricia Braly, MD         
Mary Bird Perkins Terrebonne General Hospital Recruiting
Houma, Louisiana, United States, 70360
Contact: Ann Toups       Ann.toups@tgmc.com   
Principal Investigator: Raul Doria, MD         
LSU Health Sciences- New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Renee Jenkins    504-568-2108    rjenk4@lsuhsc.edu   
Principal Investigator: Augusto Ochoa, MD         
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Alexandria Augustus    504-988-6124    aaugustu@tulane.edu   
Principal Investigator: William Robinson III, MD         
LSU Health Sciences- Shreveport Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Lori Panu    318-813-1405    lpanu@lsuhsc.edu   
Principal Investigator: Gary Burton, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Denise Cornish    734-998-7947      
Principal Investigator: Jocelyn Wiggins, MD         
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Elisabeta Levcovici    313-993-0419      
Principal Investigator: John Flack, MD         
Henry Ford Health System Active, not recruiting
Detroit, Michigan, United States, 48202
Detroit Clinical Research Center Recruiting
Novi, Michigan, United States, 48377
Contact: Sonia Amin    248-773-8979      
Principal Investigator: Mutahhar Ahmad, MD         
United States, Minnesota
Health Partners Research Foundation Recruiting
Minneapolis, Minnesota, United States, 55425
Contact: Rachel Pritchard    612-341-1957      
Principal Investigator: Karen Margolis, MD         
Phalen Village Clinic Recruiting
St. Paul, Minnesota, United States, 55106
Contact: Lea Seaquist    651-793-8640      
Principal Investigator: Kevin Peterson, MD         
United States, New Jersey
Central Jersey Medical Center Recruiting
Elizabeth, New Jersey, United States, 07202
Contact: Namrata Thakkar    908-576-8038      
Principal Investigator: Mandeep Oberoi, MD         
New Jersey Medical College Recruiting
Newark, New Jersey, United States, 07103
Contact: Yasmeen Beckett    973-972-3173    barberys@umdnj.edu   
Principal Investigator: Robert Wieder, MD, PhD         
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Nikita Watson    718-270-2931    nikita.watson@downstate.edu   
Principal Investigator: Karen Benker, MD         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Migdalia Reid    516-663-2592      
Principal Investigator: John Aloia, MD         
Queens Cancer Medical Center Recruiting
Queens, New York, United States, 11432
Contact: Linda Bulone, RN    718-883-3751    bulonel@nychhc.org   
Principal Investigator: Parampreet Bakshi, MD         
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Greensboro, North Carolina, United States, 27408
Contact: Patricia Wittmer    336-713-8243      
Principal Investigator: Jamehl Demons, MD         
The Brody School of Medicine at ECU Recruiting
Greenville, North Carolina, United States, 27834
Contact: Brittany Brown    252-744-1904      
Principal Investigator: James Powell, MD         
United States, Pennsylvania
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Julie Whinner    215-456-1959      
Principal Investigator: Gregg Pressman, MD         
University of Pittsburgh Health Sciences Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Cheryl Albig    412-383-1470      
Principal Investigator: Anne Newman, MD, MPH         
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Liz Coccio    401-729-2183      
Principal Investigator: Charles Eaton, MD         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38105
Contact: Margaret Caulfield    901-448-6732      
Principal Investigator: Suzanne Satterfield, MD         
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 57208
Contact: Donna Skupien    615-327-5725    dskupien@mmc.edu   
Principal Investigator: John Murray, MD         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Pat Knowles    214-648-3612      
Principal Investigator: Shawna Nesbitt, MD, MS         
University of TX Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Roxana Hirst    409-266-9641      
Principal Investigator: Elena Volpi, MD         
Regional Academic Health Center Recruiting
Harlingen, Texas, United States, 78550
Contact: Julia Zuniga    956-365-8688    zunigaj3@uthscsa.edu   
Principal Investigator: Sarah Espinoza, MD         
UT Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Melissa Navarro    210-450-0550      
Principal Investigator: Sarah Espinoza, MD         
Sponsors and Collaborators
Minneapolis Medical Research Foundation
National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
Investigators
Principal Investigator: Richard Grimm, MD, PHD Berman Center for Outcomes and Clinical Research
Principal Investigator: John McNeil, MD Monash University
  More Information

Additional Information:
No publications provided by Minneapolis Medical Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01038583     History of Changes
Other Study ID Numbers: 1U01AG029824-01A2
Study First Received: December 21, 2009
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:
Aspirin
Prevention
Healthy
Over 65 years old
ASPREE
Aspirin in Reducing Events in the Elderly
Australia
Functional disability
Dementia
Heart Disease/ Stroke
Cancer
Bleeding

Additional relevant MeSH terms:
Heart Diseases
Dementia
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014