Aspirin in Reducing Events in the Elderly "ASPREE"

Active, not recruiting

Phase 4 Results N/A

Update History

22 Jul '17
The description was updated.
New
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.
Old
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.
The gender criteria for eligibility was updated to "All."
23 Mar '16
The description was updated.
New
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.
Old
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.
The eligibility criteria were updated.
New
Inclusion Criteria: - Men and women - African American and Hispanic persons age 65 or older - Any person from another ethnic minority group and Caucasian persons age 70 or older - Willing and able to provide informed consent, and willing to accept the study requirements 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
Old
Inclusion Criteria: - Men and women - African American and Hispanic persons age 65 or older - Any person from another ethnic minority group and Caucasian persons age 70 or older - Willing and able to provide informed consent, and willing to accept the study requirements 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
10 Dec '14
The eligibility criteria were updated.
New
Inclusion Criteria: - Men and women - African American and Hispanic persons age 65 or older - Any person from another ethnic minority group and Caucasian persons age 70 or older - Willing and able to provide informed consent, and willing to accept the study requirements 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
Old
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
A location was updated in Birmingham.
New
The overall status was removed for The University of Alabama at Birmingham.
A location was updated in Palo Alto.
New
The overall status was removed for Palo Alto Medical Foundation Research Institute.
A location was updated in Washington.
New
The overall status was removed for Howard University.
A location was updated in Gainsville.
New
The overall status was removed for University of Florida Department of Aging and Geriatrics.
A location was updated in Atlanta.
New
The overall status was removed for Emory/ Atlanta VAMC.
A location was updated in Atlanta.
New
The overall status was removed for Morehouse School of Medicine.
A location was updated in Augusta.
New
The overall status was removed for Georgia Health Sciences University.
A location was updated in Chicago.
New
The overall status was removed for Rush Alzheimer's Disease Center.
A location was updated in Iowa City.
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The overall status was removed for University of Iowa.
A location was updated in Kansas City.
New
The overall status was removed for Kansas University Medical Center.
A location was updated in Baton Rouge.
New
The overall status was removed for Baton Rouge General.
A location was updated in Baton Rouge.
New
The overall status was removed for Mary Bird Perkins Our Lady of the Lake Cancer Center.
A location was updated in Baton Rouge.
New
The overall status was removed for Pennington Biomedical Research Center.
A location was updated in Covington.
New
The overall status was removed for Mary Bird Perkins St. Tammany Parish Hospital.
A location was updated in Houma.
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The overall status was removed for Mary Bird Perkins Terrebonne General Hospital.
A location was updated in New Orleans.
New
The overall status was removed for LSU Health Sciences- New Orleans.
A location was updated in New Orleans.
New
The overall status was removed for Tulane Medical Center.
A location was updated in Shreveport.
New
The overall status was removed for LSU Health Sciences- Shreveport.
A location was updated in Ann Arbor.
New
The overall status was removed for University of Michigan.
A location was updated in Detroit.
New
The overall status was removed for Henry Ford Health System.
A location was updated in Detroit.
New
The overall status was removed for Wayne State University.
A location was updated in Novi.
New
The overall status was removed for Detroit Clinical Research Center.
A location was updated in Minneapolis.
New
The overall status was removed for Health Partners Research Foundation.
A location was updated in St. Paul.
New
The overall status was removed for Phalen Village Clinic.
A location was updated in Elizabeth.
New
The overall status was removed for Central Jersey Medical Center.
A location was updated in Newark.
New
The overall status was removed for New Jersey Medical College.
A location was updated in Brooklyn.
New
The overall status was removed for SUNY Downstate Medical Center.
A location was updated in Mineola.
New
The overall status was removed for Winthrop University Hospital.
A location was updated in Queens.
New
The overall status was removed for Queens Cancer Medical Center.
A location was updated in Greensboro.
New
The overall status was removed for Wake Forest University Baptist Medical Center.
A location was updated in Greenville.
New
The overall status was removed for The Brody School of Medicine at ECU.
A location was updated in Philadelphia.
New
The overall status was removed for Albert Einstein Medical Center.
A location was updated in Pittsburgh.
New
The overall status was removed for University of Pittsburgh Health Sciences Research Center.
A location was updated in Pawtucket.
New
The overall status was removed for Memorial Hospital of Rhode Island.
A location was updated in Memphis.
New
The overall status was removed for University of Tennessee Health Science Center.
A location was updated in Nashville.
New
The overall status was removed for Meharry Medical College.
A location was updated in Dallas.
New
The overall status was removed for University of Texas Southwestern Medical Center at Dallas.
A location was updated in Galveston.
New
The overall status was removed for University of TX Medical Branch.
A location was updated in Harlingen.
New
The overall status was removed for Regional Academic Health Center.
A location was updated in San Antonio.
New
The overall status was removed for UT Health Science Center at San Antonio.
16 Apr '13
The Summary of Purpose was updated.
New
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.
Old
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 70. ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a disability-free life in healthy participants aged 70 years and above.
The description was updated.
New
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.
Old
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 70 years and above.
The minimum age criteria for eligibility was updated to "65 Years."
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - Men and women 70 years of age and over - Willing and able to provide informed consent, and willing to accept the study requirements 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
A location was updated in Detroit.
New
The overall status was removed for Henry Ford Health System.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - Men and women 70 years of age and over - Willing and able to provide informed consent, and willing to accept the study requirements 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
Old
Inclusion Criteria: - Men and women 70 years of age and over - Willing and able to provide informed consent, and willing to accept the study requirements 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