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

In this pragmatic, patient-centered clinical trial, we 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 atherosclerotic cardiovascular disease (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. A total of 20,000 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. We expect the entire sample of patients will be enrolled over 24 months, with a maximum follow-up of 30 months.

Other Information:

• Principal Investigators:
  • Adrian Hernandez, MD; Duke University Medical Center
  • Matthew Roe, MD, MHS; Duke University Medical Center
• GPC Principal Investigators:
  • Kamal Gupta, MD; University of Kansas Medical Center
  • Saket Girotra, MD; University of Iowa
  • Jeffrey Whittle, MD, MPH; Medical College of Wisconsin
  • Jeffrey VanWormer, PhD; Marshfield Clinic Research Foundation
  • Steven Bailey, MD; University of Texas Health Science Center at San Antonio
  • James Campbell, MD; University of Nebraska Medical Center
  • John Windle, MD; University of Nebraska Medical Center
  • Arun Kumar, MD; University of Missouri
  • Paul Dexter, MD; Indiana University
• Participating GPC Sites:
  • University of Kansas Medical Center
  • University of Iowa
  • Medical College of Wisconsin
  • Marshfield Clinic Research Foundation
  • University of Texas Health Science Center at San Antonio
  • University of Texas Southwestern Medical Center
  • University of Nebraska Medical Center
  • University of Missouri
  • Indiana University
• Status: Patients enrolling
• Start Date: Spring 2016
• Amount of Award: $14 Million
• ADAPTABLE Website
• Patient Portal
• PCORI ADAPTABLE Press Release
• PCORI Trial Fact Sheet

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