DOI: 10.3886/icpsr38609.v1
title: Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), United States, 2015-2020
title: Version 1

description: 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: 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. 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). To develop and refine the infrastructure for PCORnet to conduct multiple comparative effectiveness trials in the future. To explore biological mediators of heterogeneity of response to aspirin and of impact on clinical events.
description: 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).
description: 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.
description: None
description: 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.
description: Datasets: DS0: Study-Level Files DS1: Enrollment Criteria Data DS2: Baseline Data (Patient Reported) DS3: Baseline Data (EHR and Claims) DS4: Aspirin Data DS5: Event Level Data (Primary) DS6: Event Level Data (Sensitivity Analysis, Primary Diagnosis Only) DS7: Event Level Data (Sensitivity Analysis, All Diagnostic Positions) DS8: Event Level Data (Patient Reported Only) DS9: Event Level Data (Counting Process) DS10: Patient Reported Quality of Life Data DS11: Patient Experience Data DS12: Visit Level Data (Expected Visits) DS13: Actual Visit Data DS14: Patient Reported Medication Data DS15: Aspirin Adherence Data
description: Patients with atherosclerotic cardiovascular disease (ASCVD).
description: record abstracts; web-based surveyEach of the 15 datasets contains the deidentified respondent identification variable <strong>DEIDNUM</strong>. This variable can be used to link the files together.For more information on the ADAPTABLE study, please refer to the study website.