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

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 15000 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

Copyright © 2021 Massachusetts Medical Society.



Work Title Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial
Open Access
  1. Guillaume Marquis-Gravel
  2. Matthew T. Roe
  3. Holly R. Robertson
  4. Robert A. Harrington
  5. Michael J. Pencina
  6. Lisa G. Berdan
  7. Bradley G. Hammill
  8. Madelaine Faulkner
  9. Daniel Munõz
  10. Gregg C. Fonarow
  11. Brahmajee K. Nallamothu
  12. Dan J. Fintel
  13. Daniel E. Ford
  14. Li Zhou
  15. Sarah E. Daugherty
  16. Elizabeth Nauman
  17. Jennifer Kraschnewski
  18. Faraz S. Ahmad
  19. Catherine P. Benziger
  20. Kevin Haynes
  21. J. Greg Merritt
  22. Thomas Metkus
  23. Sunil Kripalani
  24. Kamal Gupta
  25. Raj C. Shah
  26. James C. McClay
  27. Richard N. Re
  28. Carol Geary
  29. Brent C. Lampert
  30. Steven M. Bradley
  31. Sandeep K. Jain
  32. Hani Seifein
  33. Jeff Whittle
  34. Véronique L. Roger
  35. Mark B. Effron
  36. Giselle Alvarado
  37. Ythan H. Goldberg
  38. Jeffrey L. Vanwormer
  39. Saket Girotra
  40. Peter Farrehi
  41. Kathleen M. McTigue
  42. Russell Rothman
  43. Adrian F. Hernandez
  44. W. Schuyler Jones
License In Copyright (Rights Reserved)
Work Type Article
  1. JAMA Cardiology
Publication Date May 1, 2020
Publisher Identifier (DOI)
  1. https://doi.org/10.1001/jamacardio.2020.0116
Deposited August 05, 2022




This resource is currently not in any collection.

Work History

Version 1

  • Created
  • Added ADAPTABLE_Main_NEJM_2021.pdf
  • Added Creator Guillaume Marquis-Gravel
  • Added Creator Matthew T. Roe
  • Added Creator Holly R. Robertson
  • Added Creator Robert A. Harrington
  • Added Creator Michael J. Pencina
  • Added Creator Lisa G. Berdan
  • Added Creator Bradley G. Hammill
  • Added Creator Madelaine Faulkner
  • Added Creator Daniel Munõz
  • Added Creator Gregg C. Fonarow
  • Added Creator Brahmajee K. Nallamothu
  • Added Creator Dan J. Fintel
  • Added Creator Daniel E. Ford
  • Added Creator Li Zhou
  • Added Creator Sarah E. Daugherty
  • Added Creator Elizabeth Nauman
  • Added Creator Jennifer Kraschnewski
  • Added Creator Faraz S. Ahmad
  • Added Creator Catherine P. Benziger
  • Added Creator Kevin Haynes
  • Added Creator J. Greg Merritt
  • Added Creator Thomas Metkus
  • Added Creator Sunil Kripalani
  • Added Creator Kamal Gupta
  • Added Creator Raj C. Shah
  • Added Creator James C. McClay
  • Added Creator Richard N. Re
  • Added Creator Carol Geary
  • Added Creator Brent C. Lampert
  • Added Creator Steven M. Bradley
  • Added Creator Sandeep K. Jain
  • Added Creator Hani Seifein
  • Added Creator Jeff Whittle
  • Added Creator Véronique L. Roger
  • Added Creator Mark B. Effron
  • Added Creator Giselle Alvarado
  • Added Creator Ythan H. Goldberg
  • Added Creator Jeffrey L. Vanwormer
  • Added Creator Saket Girotra
  • Added Creator Peter Farrehi
  • Added Creator Kathleen M. McTigue
  • Added Creator Russell Rothman
  • Added Creator Adrian F. Hernandez
  • Added Creator W. Schuyler Jones
  • Published
  • Withdrawn