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Special Communication
March 18, 2020

Rationale and Design of the Aspirin Dosing—A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial

Author Affiliations
  • 1Duke Clinical Research Institute, Durham, North Carolina
  • 2Duke University Medical Center, Durham, North Carolina
  • 3Department of Medicine, Stanford University, Stanford, California
  • 4Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina
  • 5Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco
  • 6Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
  • 7Department of Medicine, University of California, Los Angeles, Los Angeles
  • 8Michigan Integrated Center of Health Analytics and Medical Prediction, Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor
  • 9Feinberg School of Medicine, Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois
  • 10Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 11Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • 12Patient-Centered Outcomes Research Institute, Washington, DC
  • 13Louisiana Public Health Institute, New Orleans
  • 14Department of Medicine, Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania
  • 15Center for Health Information Partnerships, Feinberg School of Medicine, Institute of Public Health and Medicine, Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois
  • 16Essentia Health Heart and Vascular Center, Duluth, Minnesota
  • 17HealthCore Inc, Wilmington, Delaware
  • 18Patient-Centered Network of Learning Health Systems (LHSNet), Ann Arbor, Michigan
  • 19Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 20Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 21Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
  • 22Division of Cardiovascular Medicine, Department of Medicine, University of Kansas Medical Center, Kansas City
  • 23Rush Alzheimer's Disease Center, Department of Family Medicine, Rush University Medical Center, Chicago, Illinois
  • 24Department of Emergency Medicine, University of Nebraska Medical Center College of Medicine, Omaha
  • 25Ochsner Health System, New Orleans, Louisiana
  • 26University of Nebraska Medical Center, Omaha
  • 27Wexner Medical Center, Division of Cardiovascular Medicine, The Ohio State University, Columbus
  • 28Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, Minneapolis
  • 29UPMC Heart and Vascular Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • 30AdventHealth Medical Group Cardiology, Oviedo, Florida
  • 31Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, Milwaukee
  • 32Mayo Clinic, Rochester, Minnesota
  • 33Ochsner Clinical School, John Ochsner Heart and Vascular Institute, University of Queensland School of Medicine, New Orleans, Louisiana
  • 34Herbert H. Lehman College, Department of Biological Sciences, City University of New York, Bronx
  • 35Albert Einstein College of Medicine, Bronx, New York
  • 36Marshfield Clinic Research Institute, Marshfield, Wisconsin
  • 37Division of Cardiovascular Medicine, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
  • 38University of Michigan Medical School, Ann Arbor
  • 39University of Pittsburgh, Pittsburgh, Pennsylvania
  • 40Center for Health Services Research, Vanderbilt University Medical Center, Nashville, Tennessee
  • 41Associate Editor, JAMA Cardiology
JAMA Cardiol. 2020;5(5):598-607. doi:10.1001/jamacardio.2020.0116
Key Points

Question  What is the most appropriate dosage of aspirin in patients with established atherosclerotic cardiovascular disease?

Findings  This report highlights the intricate design and details of study conduct for the Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) trial. This is the first pragmatic trial using the Patient-Centered Outcomes Research network, which was developed to perform large scale comparative-effectiveness clinical trials.

Meaning  The ADAPTABLE study will help to determine the optimal dosage of aspirin in patients with established atherosclerotic cardiovascular disease.

Abstract

Importance  Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.

Objective  To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method.

Design, Setting, and Participants  This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020.

Interventions  Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily.

Main Outcomes and Measures  The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems’ common data model within the structure of PCORnet’s distributed data environment.

Conclusions and Relevance  As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD.

Trial Registration  ClinicalTrials.gov Identifier: NCT02697916

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