drugset / Trial / NCT04769362
Long-term Beta-blocker Therapy After Acute Myocardial Infarction
Phase 4
Recruiting
2540 enrolled
Samsung Medical Center
Chonbuk National University Hospital · collabChonnam National University Hospital · collabChosun University Hospital · collabChungbuk National University Hospital · collabChungnam National University Hospital · collabEwha Womans University Seoul Hospital · collabGyeongsang National University Hospital · collabInje University Ilsan Paik Hospital · collabJeju National University Hospital · collabKangbuk Samsung Hospital · collabKeimyung University Dongsan Medical Center · collabKorea University Anam Hospital · collabKyung Hee University Hospital · collabPresbyterian medical center · collabSaint Vincent's Hospital, Korea · collabSamsung Changwon Hospital · collabSejong General Hospital · collabSeoul National University Bundang Hospital · collabWonju Severance Christian Hospital · collabWonkwang University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without heart failure (HF) or left ventricular systolic dysfunction after acute myocardial infarction (AMI). Prospective, open-label, randomized, multicenter, noninferiority trial to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.
Timeline
- Start
- 2021-05-04
- Primary completion
- 2026-01-31
- Completion
- 2026-03-31
Publications
- Choi KH, Kang D, Kim W, Doh JH, Kim J, Park YH, Ahn SG, Park JP, Kim SM, Cho BR, Nam CW, Cho JH, Joo SJ, Suh J, Jeong JO, Jang WJ, Goh CW, Yoon CH, Hwang JY, Lim SH, Lee SR, Shin ES, Kim BJ, Yu CW, Her SH, Kim HK, Park KT, Kim J, Kim J, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Guallar E, Hahn JY; SMART-DECISION Investigators. Discontinuation of Beta-Blocker Therapy after Myocardial Infarction. N Engl J Med. 2026 Apr 2;394(13):1302-1312. doi: 10.1056/NEJMoa2601005. Epub 2026 Mar 30.
- Choi KH, Kim J, Kang D, Doh JH, Kim J, Park YH, Ahn SG, Kim W, Park JP, Kim SM, Cho BR, Nam CW, Cho JH, Joo SJ, Suh J, Jeong JO, Jang W, Yoon CH, Hwang JY, Lim SH, Lee SR, Shin ES, Kim BJ, Yu CW, Her SH, Kim HK, Park KT, Kim J, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Guallar E, Hahn JY; SMART-DECISION investigators. Discontinuation of beta-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial. BMJ Open. 2024 Aug 31;14(8):e086971. doi: 10.1136/bmjopen-2024-086971.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bisoprolol | Other / unclassified | — | — |
| Subject | Carvedilol | Other / unclassified | — | — |
| Subject | Nebivolol | Other / unclassified | — | — |