Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), United States, 2015-2020 (ICPSR 38609)

Version Date: Feb 6, 2023

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Principal Investigator(s):
Adrian F. Hernandez, Duke Clinical Research Institute

https://doi.org/10.3886/ICPSR38609.v1

Version V1

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Summary

The main objective of this pragmatic randomized clinical trial (PCT) is to identify the optimal dose of aspirin for secondary prevention in atherosclerotic cardiovascular disease (ASCVD). A total of 15,076 high-risk patients with a history of a myocardial infarction (MI) or documented ASCVD were randomized in a 1:1 ratio to receive 81 mgs versus 325 mgs of aspirin every day. This trial addressed the following specific aims:

  1. To compare the effectiveness of two doses of aspirin (81 mg and 325 mg) in reducing a composite of all-cause mortality and hospitalization for nonfatal MI, or nonfatal stroke, and the primary safety endpoint of major bleeding. Secondary endpoints include the components of the primary endpoint and hospitalization for transient ischemic attack, unstable angina, or coronary revascularization procedures.
  2. To compare the effects of aspirin in selected subgroups of patients by sex, age, race, Internet users vs. non-users, and those with diabetes or advanced chronic kidney disease (CKD).
  3. To develop and refine the infrastructure for PCORnet to conduct multiple comparative effectiveness trials in the future.
  4. To explore biological mediators of heterogeneity of response to aspirin and of impact on clinical events.

Citation

Hernandez, Adrian F. Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), United States, 2015-2020. Inter-university Consortium for Political and Social Research [distributor], 2023-02-06. https://doi.org/10.3886/ICPSR38609.v1

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Funding

Patient-Centered Outcomes Research Institute (ASP-1502-27079)

Subject Terms

Geographic Coverage

Restrictions

Access to the data in this collection is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.

Distributor(s)

Inter-university Consortium for Political and Social Research
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Time Period(s)

2015 -- 2020

Data Collection Notes

  1. Each of the 15 datasets contains the deidentified respondent identification variable DEIDNUM. This variable can be used to link the files together.
  2. For more information on the ADAPTABLE study, please refer to the study website.
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Study Purpose

The purpose of this study was to compare the effectiveness of two daily doses of aspirin in reducing death and hospitalization for heart attacks and strokes in a secondary prevention population of patients with atherosclerotic cardiovascular disease (ASCVD).

Study Design

Prospective, patient-level randomized controlled trial of high risk patients who have had a heart attack or have significant blockage of their coronary arteries. Patients will be randomized in a 1:1 fashion to instructions to take an aspirin dose of either 81 mg (n = 7,540) or 325 mg (n = 7,536 daily. Additionally, patients have been randomly assigned to follow-up intervals of every 3 vs 6 months. Respondents had to not be allergic to aspirin and be willing to change the dose of aspirin if they were already taking it to be included in the study.

Data collection will include use of existing electronic health records (EHR) from consenting patients in accordance with privacy and security measures, as well as a web-based patient portal to collect patient-reported outcomes (PROs) and data gathered during patients' visits with their clinicians to supplement/support the EHR. Study participants will be enrolled over 38 months. Maximum follow-up will be 50 months.

Sample

The sample of 15,076 individuals was comprised of participants who were 69% male, 80% white, 90% non-Hispanic, and an average age of 67. To be eligible for participation in the study a participant had to meet the following criteria.

  • Known ASCVD defined by prior myocardial infarction, prior coronary revascularization procedure, prior coronary angiography showing 75% or greater stenosis of at least one epicardial coronary vessel, or history of chronic ischemic heart disease, coronary artery disease, or atherosclerotic cardiovascular disease.
  • Age 18 years or older.
  • No known safety concerns or side effects considered to be related to aspirin.
  • Not currently or planned to be treated with an oral anticoagulant.
  • Not currently or planned to be treated with ticagredor.
  • Female patients who are not pregnant or nursing.
  • Estimated increased risk of a major adverse cardiovascular event (MACE) over the next 3 years by having the presence of at least one or more contributing factors.

    • Time Method

    Longitudinal: Panel

    Universe

    Patients with atherosclerotic cardiovascular disease (ASCVD).

    Unit(s) of Observation

    Individual

    Data Type(s)

    Mode of Data Collection

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    Original Release Date

    2023-02-06

    Version History

    2023-02-06 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:

    • Checked for undocumented or out-of-range codes.

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    Weight

    None

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    Notes

    • The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.

    • One or more files in this data collection have special restrictions. Restricted data files are not available for direct download from the website; click on the Restricted Data button to learn more.