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

Completed · Not applicable

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

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.

Key facts

Study ID: NCT02697916
Run by: Duke University
People needed: 15076
Starts: 2016-04-01
Expected to finish: 2020-06-30
Last updated by the study team: 2021-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

UCLA Medical Center — Los Angeles, California, United States
HealthCore — Wilmington, Delaware, United States
University of Florida Cardiology - Springhill — Gainesville, Florida, United States
Florida Hospital — Orlando, Florida, United States
Orlando Health — Orlando, Florida, United States
Bond Community Health Center — Tallahassee, Florida, United States
Northwestern University — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Chicago Medical Center — Chicago, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Ochsner Health System — New Orleans, Louisiana, United States
Tulane University Heart & Vascular Institute — New Orleans, Louisiana, United States
Johns Hopkins Medical Center — Baltimore, Maryland, United States
University of Michigan — Ann Arbor, Michigan, United States
Essentia Health St. Mary's Medical Center — Duluth, Minnesota, United States
Allina Health — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
University of Missouri — Columbia, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
New York University School of Medicine — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Weill Cornell Medicine of Cornell University — New York, New York, United States
Montefiore Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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