drugset / Trial / NCT02697916
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term
Completed
15076 enrolled
Duke University
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN) · collabGreater Plains Collaborative Clinical Data Research Network · collabHealthCore-Anthem Research Network · collabHumana Inc. · collabMedidata Solutions · collabMid-South Clinical Data Research Network · collabNew York City Clinical Data Research Network · collabOneFlorida Clinical Data Research Network · collabPaTH Clinical Data Research Network · collabPatient-Centered Outcomes Research Institute · collabResearch Action for Health Network (REACHnet) · collabThe Health eHeart Alliance · collabThe Patient-Centered Network of Learning Health Systems · collabThe Patient-Oriented Scalable National Network for Effectiveness Research · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2016-04
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 81 mg | — |
| Comparator | Aspirin | Small molecule | 325 mg | — |