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Atherosclerotic Cardiovascular DiseaseADAPTABLENCT02697916

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

A study testing aspirin in people with Atherosclerotic Cardiovascular Disease, run by Duke University at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerotic Cardiovascular Disease
What is being tested?
aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,076 participants
Where
40 sitesUnited States
Study dates
Apr 2016to 30 Jun 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Johns Hopkins Medical Center

    Baltimore, Maryland, 21287

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Missouri

    Columbia, Missouri, 65211

  • Ohio State Univerity

    Columbus, Ohio, 43210

  • Baylor Scott and White Heart and Vascular Hospital

    Dallas, Texas, 75226

  • University of Texas-Southwestern

    Dallas, Texas, 75390

  • Essentia Health St. Mary's Medical Center

    Duluth, Minnesota, 55805

  • Duke University

    Durham, North Carolina, 27701

  • University of Florida Cardiology - Springhill

    Gainesville, Florida, 32606

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Allina Health

    Minneapolis, Minnesota, 55407

  • Vanderbilt University

    Nashville, Tennessee, 37203

  • Ochsner Health System

    New Orleans, Louisiana, 70112

  • Tulane University Heart & Vascular Institute

    New Orleans, Louisiana, 70112

  • New York University School of Medicine

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Weill Cornell Medicine of Cornell University

    New York, New York, 10065

  • Montefiore Medical Center

    New York, New York, 10461

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68196

  • Florida Hospital

    Orlando, Florida, 32806

  • Orlando Health

    Orlando, Florida, 32806

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

  • University of Utah Hospitals and Clinics

    Salt Lake City, Utah, 84112

  • University of Texas Health Sciences Center at San Antonio

    San Antonio, Texas, 78229

  • Bond Community Health Center

    Tallahassee, Florida, 32301

  • HealthCore

    Wilmington, Delaware, 19801

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
aspirin
Keywords
aspirin, ACSD, PCORI
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirinDrug

    Also called ASA

    81mg of aspirin daily vs. 325mg of aspirin daily

Study groups in NCT02697916
Study groupRoleWhat they receive
ASA 81mgActive comparatoraspirin 81mg
Receives: Drug: aspirin
ASA 325mgActive comparatoraspirin 325mg
Receives: Drug: aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Time of randomization through study completion, approximately 4 years

Secondary outcomes (5)

  1. Number of Participants Experiencing All-cause Death

    Measured: Time of randomization through study completion, approximately 4 years

  2. Number of Participants Experiencing Hospitalization for Nonfatal MI

    Measured: Time of randomization through study completion, approximately 4 years

  3. Number of Participants Experiencing Hospitalization for Nonfatal Stroke

    Measured: Time of randomization through study completion, approximately 4 years

  4. Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])

    Measured: Time of randomization through study completion, approximately 4 years

  5. Quality of Life and Functional Status, as Measured on a 5-point Scale

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15,076 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02697916
Sponsor's protocol ID
Pro00068525
Acronym
ADAPTABLE
Status last verified
Jun 2021
First submitted
18 Feb 2016
Last updated
1 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
No

Publications

  • Narcisse DI, Whittle J, Rhodes GM, Stebbins AL, Wruck LM, Mulder H, Kripalani S, Munoz D, Effron MB, Gupta K, Handberg EM, Girotra S, Hess R, Benziger CP, Farrehi P, VanWormer JJ, Knowlton KU, Polonsky TS, Bradley SM, Robertson HR, Hammill BG, Rothman RL, Harrington RA, Jones WS, Hernandez AF. Association of study visit interval length with follow-up completeness and adherence to assigned study drug dose: A randomized comparison of participants in the ADAPTABLE trial. Contemp Clin Trials. 2025 Sep;156:108030. doi: 10.1016/j.cct.2025.108030. Epub 2025 Jul 25.

    PubMed 40716702

  • Marquis-Gravel G, Mulder H, Wruck LM, Benziger CP, Effron MB, Farrehi PM, Girotra S, Gupta K, Kripalani S, Munoz D, Polonsky TS, Whittle J, Harrington R, Rothman R, Hernandez AF, Jones WS. Impact of aspirin dose according to race in secondary prevention of atherosclerotic cardiovascular disease: a secondary analysis of the ADAPTABLE randomised controlled trial. BMJ Open. 2024 Aug 7;14(8):e078197. doi: 10.1136/bmjopen-2023-078197.

    PubMed 39117415

  • Benziger CP, Stebbins A, Wruck LM, Effron MB, Marquis-Gravel G, Farrehi PM, Girotra S, Gupta K, Kripalani S, Munoz D, Polonsky TS, Sharlow A, Whittle J, Harrington RA, Rothman RL, Hernandez AF, Jones WS. Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Male and Female Patients: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):808-816. doi: 10.1001/jamacardio.2024.1712.

    PubMed 38985488

  • Marquis-Gravel G, Stebbins A, Wruck LM, Roe MT, Effron MB, Hammill BG, Whittle J, VanWormer JJ, Robertson HR, Alikhaani JD, Kripalani S, Farrehi PM, Girotra S, Benziger CP, Polonsky TS, Merritt JG, Gupta K, McCormick TE 3rd, Knowlton KU, Jain SK, Kochar A, Rothman RL, Harrington RA, Hernandez AF, Jones WS. Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e026921. doi: 10.1161/JAHA.122.026921. Epub 2024 Feb 13.

    PubMed 38348779

  • Girotra S, Stebbins A, Wruck L, Marquis-Gravel G, Gupta K, Farrehi P, Benziger CP, Effron MB, Whittle J, Munoz D, Kripalani S, Anderson RD, Jain SK, Polonsky TS, Ahmad FS, Roe MT, Rothman RL, Harrington RA, Hernandez AF, Jones WS. Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors. J Am Heart Assoc. 2023 Oct 17;12(20):e030385. doi: 10.1161/JAHA.123.030385. Epub 2023 Oct 13.

    PubMed 37830344

  • Sleem A, Effron MB, Stebbins A, Wruck LM, Marquis-Gravel G, Munoz D, Re RN, Gupta K, Pepine CJ, Jain SK, Girotra S, Whittle J, Benziger CP, Farrehi PM, Knowlton KU, Polonsky TS, Roe MT, Rothman RL, Harrington RA, Jones WS, Hernandez AF. Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol. 2023 Nov 1;8(11):1061-1069. doi: 10.1001/jamacardio.2023.3364.

    PubMed 37792369

  • Shen R, Mulder H, Wruck L, Weissler EH, Robertson HR, Sharlow AG, Kripalani S, Munoz D, Effron MB, Gupta K, Girotra S, Whittle J, Benziger CP, VanWormer JJ, Polonsky TS, Rothman RL, Harrington RA, Hernandez AF, Jones WS. Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study. J Am Heart Assoc. 2023 Jul 4;12(13):e027899. doi: 10.1161/JAHA.122.027899. Epub 2023 Jun 22.

    PubMed 37345815

  • Weissler EH, Stebbins A, Wruck L, Munoz D, Gupta K, Girotra S, Whittle J, Benziger CP, Polonsky TS, Bradley SM, Hammill BG, Merritt JG, Zemon DN, Hernandez AF, Jones WS. Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study. Vasc Med. 2023 Apr;28(2):122-130. doi: 10.1177/1358863X231154951.

    PubMed 37025023

  • O'Brien EC, Mulder H, Jones WS, Hammill BG, Sharlow A, Hernandez AF, Curtis LH. Concordance Between Patient-Reported Health Data and Electronic Health Data in the ADAPTABLE Trial. JAMA Cardiol. 2022 Dec 1;7(12):1235-1243. doi: 10.1001/jamacardio.2022.3844.

    PubMed 36322059

  • Marquis-Gravel G, Faulkner M, Merritt G, Farrehi P, Zemon N, Robertson HR, Jones WS, Kraschnewski J. Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience. Clin Trials. 2023 Feb;20(1):31-35. doi: 10.1177/17407745221118559. Epub 2022 Aug 23.

    PubMed 35999816

  • Jones WS, Mulder H, Wruck LM, Pencina MJ, Kripalani S, Munoz D, Crenshaw DL, Effron MB, Re RN, Gupta K, Anderson RD, Pepine CJ, Handberg EM, Manning BR, Jain SK, Girotra S, Riley D, DeWalt DA, Whittle J, Goldberg YH, Roger VL, Hess R, Benziger CP, Farrehi P, Zhou L, Ford DE, Haynes K, VanWormer JJ, Knowlton KU, Kraschnewski JL, Polonsky TS, Fintel DJ, Ahmad FS, McClay JC, Campbell JR, Bell DS, Fonarow GC, Bradley SM, Paranjape A, Roe MT, Robertson HR, Curtis LH, Sharlow AG, Berdan LG, Hammill BG, Harris DF, Qualls LG, Marquis-Gravel G, Modrow MF, Marcus GM, Carton TW, Nauman E, Waitman LR, Kho AN, Shenkman EA, McTigue KM, Kaushal R, Masoudi FA, Antman EM, Davidson DR, Edgley K, Merritt JG, Brown LS, Zemon DN, McCormick TE 3rd, Alikhaani JD, Gregoire KC, Rothman RL, Harrington RA, Hernandez AF; ADAPTABLE Team. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease. N Engl J Med. 2021 May 27;384(21):1981-1990. doi: 10.1056/NEJMoa2102137. Epub 2021 May 15.

    PubMed 33999548

  • Ahmad FS, Ricket IM, Hammill BG, Eskenazi L, Robertson HR, Curtis LH, Dobi CD, Girotra S, Haynes K, Kizer JR, Kripalani S, Roe MT, Roumie CL, Waitman R, Jones WS, Weiner MG. Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE. Circ Cardiovasc Qual Outcomes. 2020 Jun;13(6):e006292. doi: 10.1161/CIRCOUTCOMES.119.006292. Epub 2020 May 29.

    PubMed 32466729

  • Marquis-Gravel G, Roe MT, Robertson HR, Harrington RA, Pencina MJ, Berdan LG, Hammill BG, Faulkner M, Munoz D, Fonarow GC, Nallamothu BK, Fintel DJ, Ford DE, Zhou L, Daugherty SE, Nauman E, Kraschnewski J, Ahmad FS, Benziger CP, Haynes K, Merritt JG, Metkus T, Kripalani S, Gupta K, Shah RC, McClay JC, Re RN, Geary C, Lampert BC, Bradley SM, Jain SK, Seifein H, Whittle J, Roger VL, Effron MB, Alvarado G, Goldberg YH, VanWormer JL, Girotra S, Farrehi P, McTigue KM, Rothman R, Hernandez AF, Jones WS. Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial. JAMA Cardiol. 2020 May 1;5(5):598-607. doi: 10.1001/jamacardio.2020.0116.

    PubMed 32186653

Questions about this trial

What is this clinical trial studying?

A study testing aspirin in people with Atherosclerotic Cardiovascular Disease, run by Duke University at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02697916, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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