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

NCT02697916 | Completed Results DMC

• 1 other identifier: Pro00068525
• Study Type: interventional
• Target: 15,076
• Locations: 1 country
• Sites: 40

Brief 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. 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.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

aspirin; ACSD; PCORI

Outcome Measures

Primary Outcomes (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)

  Time of randomization through study completion, approximately 4 years

Secondary Outcomes (5)

• Number of Participants Experiencing All-cause Death

  Time of randomization through study completion, approximately 4 years

• Number of Participants Experiencing Hospitalization for Nonfatal MI

  Time of randomization through study completion, approximately 4 years

• Number of Participants Experiencing Hospitalization for Nonfatal Stroke

  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 of randomization through study completion, approximately 4 years

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

  2 years

Other Outcomes (1)

• Number of Participants Experiencing Hospitalization for Major Bleeding Complications With an Associated Blood Product Transfusion

  Time of randomization through study completion, approximately 4 years

Study Arms (2)

ASA 81mg

ACTIVE COMPARATOR

aspirin 81mg

Drug: aspirin

ASA 325mg

ACTIVE COMPARATOR

aspirin 325mg

Drug: aspirin

Interventions

aspirin DRUG

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

Also known as: ASA

ASA 325mg; ASA 81mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• vessel coronary artery disease

You may not qualify if:

• Patients and sites interested in participating must be part of the listed health systems collaborators.

Sponsors & Collaborators

• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Medidata Solutions: collaborator
• Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN): collaborator
• Greater Plains Collaborative Clinical Data Research Network: collaborator
• Mid-South Clinical Data Research Network: collaborator
• Research Action for Health Network (REACHnet): collaborator
• The Patient-Oriented Scalable National Network for Effectiveness Research: collaborator
• PaTH Clinical Data Research Network: collaborator
• New York City Clinical Data Research Network: collaborator
• The Health eHeart Alliance: collaborator
• OneFlorida Clinical Data Research Network: collaborator
• HealthCore-Anthem Research Network: collaborator
• Humana Inc.: collaborator
• The Patient-Centered Network of Learning Health Systems: collaborator

Study Sites (40)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

HealthCore

Wilmington, Delaware, 19801, United States

Location

University of Florida Cardiology - Springhill

Gainesville, Florida, 32606, United States

Location

Florida Hospital

Orlando, Florida, 32806, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Bond Community Health Center

Tallahassee, Florida, 32301, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70112, United States

Location

Tulane University Heart & Vascular Institute

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Essentia Health St. Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

Allina Health

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Missouri

Columbia, Missouri, 65211, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68196, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medicine of Cornell University

New York, New York, 10065, United States

Location

Montefiore Medical Center

New York, New York, 10461, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State Univerity

Columbus, Ohio, 43210, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

University of Texas-Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84112, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (12)

• 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.

  PMID: 40716702 DERIVED

• 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.

  PMID: 39117415 DERIVED

• 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.

  PMID: 38985488 DERIVED

• 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.

  PMID: 37830344 DERIVED

• 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.

  PMID: 37792369 DERIVED

• 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.

  PMID: 37345815 DERIVED

• 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.

  PMID: 37025023 DERIVED

• 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.

  PMID: 36322059 DERIVED

• 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.

  PMID: 35999816 DERIVED

• 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.

  PMID: 33999548 DERIVED

• 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.

  PMID: 32466729 DERIVED

• 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.

  PMID: 32186653 DERIVED

Related Links

• ADAPTABLE public website

MeSH Terms

Conditions

Atherosclerosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: W. Schuyler Jones, MD
• Organization: Duke University; Duke Clinical Research Institute

schuyler.jones@duke.edu

919-668-8917

Study Officials

• William S. Jones, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Adrian F. Hernandez, MD MHS FAHA

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 3, 2016
• Study Start: April 1, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 1, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Locations

US (40)