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

June 9, 2021 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15076

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • HealthCore
    • Florida
      • Gainesville, Florida, United States, 32606
        • University of Florida Cardiology - Springhill
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Orlando, Florida, United States, 32806
        • Florida Hospital
      • Tallahassee, Florida, United States, 32301
        • Bond Community Health Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Ochsner Health System
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Heart & Vascular Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health St. Mary's Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri
    • Nebraska
      • Omaha, Nebraska, United States, 68196
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10065
        • Weill Cornell Medicine of Cornell University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Chapel Hill
      • Durham, North Carolina, United States, 27701
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State Univerity
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Scott and White Heart and Vascular Hospital
      • Dallas, Texas, United States, 75390
        • University of Texas-Southwestern
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Sciences Center at San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Hospitals and Clinics
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ASA 81mg
aspirin 81mg
Drug: aspirin
81mg of aspirin daily vs. 325mg of aspirin daily
Other Names:
  • ASA
Active Comparator: ASA 325mg
aspirin 325mg
Drug: aspirin
81mg of aspirin daily vs. 325mg of aspirin daily
Other Names:
  • ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time of randomization through study completion, approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing All-cause Death
Time Frame: Time of randomization through study completion, approximately 4 years
Time of randomization through study completion, approximately 4 years
Number of Participants Experiencing Hospitalization for Nonfatal MI
Time Frame: Time of randomization through study completion, approximately 4 years
Time of randomization through study completion, approximately 4 years
Number of Participants Experiencing Hospitalization for Nonfatal Stroke
Time Frame: Time of randomization through study completion, approximately 4 years
Time of randomization through study completion, approximately 4 years
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
Time of randomization through study completion, approximately 4 years
Quality of Life and Functional Status, as Measured on a 5-point Scale
Time Frame: 2 years
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.
2 years

Other Outcome Measures

Outcome Measure
Time Frame
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
Time of randomization through study completion, approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Patient-Centered Outcomes Research Institute
Research Action for Health Network (REACHnet)
New York City Clinical Data Research Network
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
Greater Plains Collaborative Clinical Data Research Network
Mid-South Clinical Data Research Network
Mytrus
Patient-Centered Scalable National Network for Effectiveness Research
PaTH 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

Investigators

  • Principal Investigator: William S. Jones, MD, Duke Clinical Research Institute
  • Principal Investigator: Adrian F. Hernandez, MD MHS FAHA, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00068525

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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