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Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term (ADAPTABLE)

Primary Purpose

Atherosclerotic Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aspirin
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerotic Cardiovascular Disease focused on measuring aspirin, ACSD, PCORI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Medical Center
  • HealthCore
  • University of Florida Cardiology - Springhill
  • Florida Hospital
  • Orlando Health
  • Bond Community Health Center
  • Northwestern University
  • Rush University Medical Center
  • University of Chicago Medical Center
  • Indiana University
  • University of Iowa Hospitals & Clinics
  • University of Kansas Medical Center
  • Ochsner Health System
  • Tulane University Heart & Vascular Institute
  • Johns Hopkins Medical Center
  • University of Michigan
  • Essentia Health St. Mary's Medical Center
  • Allina Health
  • Mayo Clinic
  • University of Missouri
  • University of Nebraska Medical Center
  • New York University School of Medicine
  • Icahn School of Medicine at Mount Sinai
  • Weill Cornell Medicine of Cornell University
  • Montefiore Medical Center
  • UNC Chapel Hill
  • Duke University
  • Wake Forest University Health Sciences
  • Ohio State Univerity
  • Penn State Milton S Hershey Medical Center
  • Temple University Hospital
  • University of Pittsburgh Medical Center
  • Vanderbilt University
  • Baylor Scott and White Heart and Vascular Hospital
  • University of Texas-Southwestern
  • University of Texas Health Sciences Center at San Antonio
  • Intermountain Medical Center
  • University of Utah Hospitals and Clinics
  • Marshfield Clinic
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ASA 81mg

ASA 325mg

Arm Description

aspirin 81mg

aspirin 325mg

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of Participants Experiencing All-cause Death
Number of Participants Experiencing Hospitalization for Nonfatal MI
Number of Participants Experiencing Hospitalization for Nonfatal Stroke
Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])
Quality of Life and Functional Status, as Measured on a 5-point Scale
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.

Full Information

First Posted
February 18, 2016
Last Updated
June 9, 2021
Sponsor
Duke University
Collaborators
Patient-Centered Outcomes Research Institute, Mytrus, Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), Greater Plains Collaborative Clinical Data Research Network, Mid-South Clinical Data Research Network, Research Action for Health Network (REACHnet), Patient-Centered Scalable National Network for Effectiveness Research, PaTH Clinical Data Research Network, New York City Clinical Data Research Network, Health eHeart Patient Powered Network, OneFlorida Clinical Data Research Network, HealthCore-Anthem Research Network, Humana-HUMnet, The Patient-Centered Network of Learning Health Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02697916
Brief Title
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term
Acronym
ADAPTABLE
Official Title
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Patient-Centered Outcomes Research Institute, Mytrus, Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), Greater Plains Collaborative Clinical Data Research Network, Mid-South Clinical Data Research Network, Research Action for Health Network (REACHnet), Patient-Centered Scalable National Network for Effectiveness Research, PaTH Clinical Data Research Network, New York City Clinical Data Research Network, Health eHeart Patient Powered Network, OneFlorida Clinical Data Research Network, HealthCore-Anthem Research Network, Humana-HUMnet, The Patient-Centered Network of Learning Health Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease
Keywords
aspirin, ACSD, PCORI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15076 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASA 81mg
Arm Type
Active Comparator
Arm Description
aspirin 81mg
Arm Title
ASA 325mg
Arm Type
Active Comparator
Arm Description
aspirin 325mg
Intervention Type
Drug
Intervention Name(s)
aspirin
Other Intervention Name(s)
ASA
Intervention Description
81mg of aspirin daily vs. 325mg of aspirin daily
Primary Outcome Measure Information:
Title
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)
Time Frame
Time of randomization through study completion, approximately 4 years
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing All-cause Death
Time Frame
Time of randomization through study completion, approximately 4 years
Title
Number of Participants Experiencing Hospitalization for Nonfatal MI
Time Frame
Time of randomization through study completion, approximately 4 years
Title
Number of Participants Experiencing Hospitalization for Nonfatal Stroke
Time Frame
Time of randomization through study completion, approximately 4 years
Title
Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])
Time Frame
Time of randomization through study completion, approximately 4 years
Title
Quality of Life and Functional Status, as Measured on a 5-point Scale
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Number of Participants Experiencing Hospitalization for Major Bleeding Complications With an Associated Blood Product Transfusion
Time Frame
Time of randomization through study completion, approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William S. Jones, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian F. Hernandez, MD MHS FAHA
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
HealthCore
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
University of Florida Cardiology - Springhill
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Bond Community Health Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32301
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University Heart & Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Essentia Health St. Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Allina Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68196
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medicine of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State Univerity
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Scott and White Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
University of Texas-Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Sciences Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36322059
Citation
O'Brien EC, Mulder H, Jones WS, Hammill BG, Sharlow A, Hernandez AF, Curtis LH. Concordance Between Patient-Reported Health Data and Electronic Health Data in the ADAPTABLE Trial. JAMA Cardiol. 2022 Dec 1;7(12):1235-1243. doi: 10.1001/jamacardio.2022.3844.
Results Reference
derived
PubMed Identifier
33999548
Citation
Jones WS, Mulder H, Wruck LM, Pencina MJ, Kripalani S, Munoz D, Crenshaw DL, Effron MB, Re RN, Gupta K, Anderson RD, Pepine CJ, Handberg EM, Manning BR, Jain SK, Girotra S, Riley D, DeWalt DA, Whittle J, Goldberg YH, Roger VL, Hess R, Benziger CP, Farrehi P, Zhou L, Ford DE, Haynes K, VanWormer JJ, Knowlton KU, Kraschnewski JL, Polonsky TS, Fintel DJ, Ahmad FS, McClay JC, Campbell JR, Bell DS, Fonarow GC, Bradley SM, Paranjape A, Roe MT, Robertson HR, Curtis LH, Sharlow AG, Berdan LG, Hammill BG, Harris DF, Qualls LG, Marquis-Gravel G, Modrow MF, Marcus GM, Carton TW, Nauman E, Waitman LR, Kho AN, Shenkman EA, McTigue KM, Kaushal R, Masoudi FA, Antman EM, Davidson DR, Edgley K, Merritt JG, Brown LS, Zemon DN, McCormick TE 3rd, Alikhaani JD, Gregoire KC, Rothman RL, Harrington RA, Hernandez AF; ADAPTABLE Team. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease. N Engl J Med. 2021 May 27;384(21):1981-1990. doi: 10.1056/NEJMoa2102137. Epub 2021 May 15.
Results Reference
derived
PubMed Identifier
32466729
Citation
Ahmad FS, Ricket IM, Hammill BG, Eskenazi L, Robertson HR, Curtis LH, Dobi CD, Girotra S, Haynes K, Kizer JR, Kripalani S, Roe MT, Roumie CL, Waitman R, Jones WS, Weiner MG. Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE. Circ Cardiovasc Qual Outcomes. 2020 Jun;13(6):e006292. doi: 10.1161/CIRCOUTCOMES.119.006292. Epub 2020 May 29.
Results Reference
derived
PubMed Identifier
32186653
Citation
Marquis-Gravel G, Roe MT, Robertson HR, Harrington RA, Pencina MJ, Berdan LG, Hammill BG, Faulkner M, Munoz D, Fonarow GC, Nallamothu BK, Fintel DJ, Ford DE, Zhou L, Daugherty SE, Nauman E, Kraschnewski J, Ahmad FS, Benziger CP, Haynes K, Merritt JG, Metkus T, Kripalani S, Gupta K, Shah RC, McClay JC, Re RN, Geary C, Lampert BC, Bradley SM, Jain SK, Seifein H, Whittle J, Roger VL, Effron MB, Alvarado G, Goldberg YH, VanWormer JL, Girotra S, Farrehi P, McTigue KM, Rothman R, Hernandez AF, Jones WS. Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial. JAMA Cardiol. 2020 May 1;5(5):598-607. doi: 10.1001/jamacardio.2020.0116.
Results Reference
derived
Links:
URL
http://theaspirinstudy.org/
Description
ADAPTABLE public website

Learn more about this trial

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term

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