Brief Summary
ADAPTABLE is a pragmatic clinical trial in which 15,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. Study participants will be enrolled over 38 months. Maximum follow-up will be 50 months. The purpose of the study is to identify the optimal dose of aspirin for secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The primary endpoint is a composite of all-cause death, hospitalization for MI, or hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding with an associated blood product transfusion.
Brief Title
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term
Detailed Description
In this pragmatic, patient-centered clinical trial, the investigators will compare the effectiveness of two doses of aspirin (81 mg and 325 mg) currently in widespread use in the United States in the secondary-prevention population of patients with established ASCVD. The trial will use a novel format that uses existing electronic health records (EHRs), as well as a web-based patient portal to collect patient-reported outcomes (PROs), and available patient encounter data to supplement/support the EHR. Patients who are identified as candidates for the trial will be directed to the electronic patient portal for the eConsent as well as an abbreviated eligibility confirmation and randomization. One of the important aims of ADAPTABLE is to engage patients, their healthcare providers, and trial investigators in using the infrastructure PCORnet has developed and continues to refine. A total of 15,000 high-risk patients with ASCVD will be randomly assigned (in an open-label fashion) in a 1:1 ratio to instructions to use a daily aspirin dose of either 81 mg or 325 mg daily. The investigators expect the entire sample of patients will be enrolled over 38 months, with a maximum follow-up of 50 months.
Completion Date
Completion Date Type
Actual
Conditions
Atherosclerotic Cardiovascular Disease
Eligibility Criteria
Inclusion Criteria:
* Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
* Age ≥ 18 years
* No known safety concerns or side effects considered to be related to aspirin, including
* No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
* No history of significant GI bleed within the past 12 months
* Significant bleeding disorders that preclude the use of aspirin
* Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
* Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
* Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
* Female patients who are not pregnant or nursing an infant
* Estimated risk of a major cardiovascular event (MACE) \> 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
* Age \> 65 years
* Serum creatinine \> 1.5 mg/dL
* Diabetes mellitus (Type 1 or Type 2)
* 3-vessel coronary artery disease
* Cerebrovascular disease and/or peripheral arterial disease
* Left ventricular ejection fraction (LVEF) \< 50%
* Current cigarette smoker
* Chronic systolic or diastolic heart failure
* SBP \> 140 (within past 12 mos)
* LDL \> 130 (within past 12 mos)
Exclusion Criteria:
* There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
* Patients and sites interested in participating must be part of the listed health systems collaborators.
* Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
* Age ≥ 18 years
* No known safety concerns or side effects considered to be related to aspirin, including
* No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
* No history of significant GI bleed within the past 12 months
* Significant bleeding disorders that preclude the use of aspirin
* Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
* Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
* Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
* Female patients who are not pregnant or nursing an infant
* Estimated risk of a major cardiovascular event (MACE) \> 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
* Age \> 65 years
* Serum creatinine \> 1.5 mg/dL
* Diabetes mellitus (Type 1 or Type 2)
* 3-vessel coronary artery disease
* Cerebrovascular disease and/or peripheral arterial disease
* Left ventricular ejection fraction (LVEF) \< 50%
* Current cigarette smoker
* Chronic systolic or diastolic heart failure
* SBP \> 140 (within past 12 mos)
* LDL \> 130 (within past 12 mos)
Exclusion Criteria:
* There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
* Patients and sites interested in participating must be part of the listed health systems collaborators.
Inclusion Criteria
Inclusion Criteria:
* Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
* Age ≥ 18 years
* No known safety concerns or side effects considered to be related to aspirin, including
* No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
* No history of significant GI bleed within the past 12 months
* Significant bleeding disorders that preclude the use of aspirin
* Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
* Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
* Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
* Female patients who are not pregnant or nursing an infant
* Estimated risk of a major cardiovascular event (MACE) \> 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
* Age \> 65 years
* Serum creatinine \> 1.5 mg/dL
* Diabetes mellitus (Type 1 or Type 2)
* 3-vessel coronary artery disease
* Cerebrovascular disease and/or peripheral arterial disease
* Left ventricular ejection fraction (LVEF) \< 50%
* Current cigarette smoker
* Chronic systolic or diastolic heart failure
* SBP \> 140 (within past 12 mos)
* LDL \> 130 (within past 12 mos)
* Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
* Age ≥ 18 years
* No known safety concerns or side effects considered to be related to aspirin, including
* No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
* No history of significant GI bleed within the past 12 months
* Significant bleeding disorders that preclude the use of aspirin
* Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
* Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
* Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
* Female patients who are not pregnant or nursing an infant
* Estimated risk of a major cardiovascular event (MACE) \> 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
* Age \> 65 years
* Serum creatinine \> 1.5 mg/dL
* Diabetes mellitus (Type 1 or Type 2)
* 3-vessel coronary artery disease
* Cerebrovascular disease and/or peripheral arterial disease
* Left ventricular ejection fraction (LVEF) \< 50%
* Current cigarette smoker
* Chronic systolic or diastolic heart failure
* SBP \> 140 (within past 12 mos)
* LDL \> 130 (within past 12 mos)
Gender
All
Gender Based
false
Keywords
aspirin
ACSD
PCORI
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02697916
Org Class
Other
Org Full Name
Duke University
Org Study Id
Pro00068525
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness
Primary Outcomes
Outcome Measure
Number of Participants Experiencing All-cause Death, Hospitalization for Nonfatal MI, or Hospitalization for Nonfatal Stroke in High-risk Patients With a History of MI or Documented Atherosclerotic Cardiovascular Disease (ASCVD)
Outcome Time Frame
Time of randomization through study completion, approximately 4 years
Secondary Outcomes
Outcome Time Frame
Time of randomization through study completion, approximately 4 years
Outcome Measure
Number of Participants Experiencing All-cause Death
Outcome Time Frame
Time of randomization through study completion, approximately 4 years
Outcome Measure
Number of Participants Experiencing Hospitalization for Nonfatal MI
Outcome Time Frame
Time of randomization through study completion, approximately 4 years
Outcome Measure
Number of Participants Experiencing Hospitalization for Nonfatal Stroke
Outcome Time Frame
Time of randomization through study completion, approximately 4 years
Outcome Measure
Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])
Outcome Description
Quality of life measures are based on an ordinal scale from 1-5, where 1 corresponds to the best outcome and 5 to the worst. Model-based mean score estimates are obtained from mixed models of each quality of life measure.
Outcome Time Frame
2 years
Outcome Measure
Quality of Life and Functional Status, as Measured on a 5-point Scale
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ythan Goldberg
Investigator Email
ygoldber@montefiore.org
Investigator Phone
718-904-3253
Categories Mesh Debug
Heart/Cardiovascular --- ARTERIOSCLEROSIS
Heart/Cardiovascular --- ARTERIAL OCCLUSIVE DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ATHEROSCLEROSIS
ARTERIOSCLEROSIS
ARTERIAL OCCLUSIVE DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
ASPIRIN
SALICYLATES
HYDROXYBENZOATES
PHENOLS
BENZENE DERIVATIVES
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
ORGANIC CHEMICALS