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| Name | Class |
|---|---|
| Kangbuk Samsung Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Kyung Hee University Hospital | OTHER |
| Keimyung University Dongsan Medical Center |
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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.
β-blockers have anti-ischemic, anti-arrhythmic, and anti-adrenergic properties. In order to reduce cardiovascular mortality and morbidity, current major guidelines recommend that oral treatment of β-blockers should be continued during and after hospitalization in patients with acute myocardial infarction (AMI) and without contraindications to β-blocker use.
A clinically important but difficult decision on β-blocker therapy after AMI is to determine the duration of β-blocker therapy after discharge in patients without heart failure (HF) or left ventricular systolic dysfunction. Previous studies for long-term β-blocker therapy after AMI were inadequate to derive definite conclusion because of small sample size and potential selection bias.
Therefore, the SMART-DECISION trial will investigate 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| β-blocker discontinuation arm | Experimental | Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction |
|
| β-blocker maintenance arm | No Intervention | Continuation of β-blocker therapy after acute myocardial infarction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontinuation of β-blocker | Drug | Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | a composite of all-cause death, myocardial infarction, hospitalization for heart failure | 2.5 years after last patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | 2.5 years after last patient enrollment | |
| Cardiovascular death | 2.5 years after last patient enrollment | |
| Myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joo-Yong Hahn, MD,PhD | Contact | 82-2-3410-6653 | jyhahn@skku.edu | |
| Ki Hong Choi | Contact | 82-2-3410-3419 | cardiokh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joo-Yong Hahn, MD,PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910427 | Derived | 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. | |
| 39645270 |
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After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| OTHER |
| Korea University Anam Hospital | OTHER |
| Sejong General Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Samsung Changwon Hospital | OTHER |
| Saint Vincent's Hospital, Korea | OTHER |
| Presbyterian medical center | UNKNOWN |
| Wonkwang University Hospital | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Ewha Womans University Seoul Hospital | OTHER |
| Inje University Ilsan Paik Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
| Chonnam National University Hospital | OTHER |
| Jeju National University Hospital | OTHER |
| Chosun University Hospital | OTHER |
| Chungbuk National University Hospital | OTHER |
| Chungnam National University Hospital | OTHER |
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| 2.5 years after last patient enrollment |
| Any hospitalization | 2.5 years after last patient enrollment |
| Hospitalization for heart failure | 2.5 years after last patient enrollment |
| Hospitalization for acute coronary syndrome | 2.5 years after last patient enrollment |
| All-cause death or myocardial infarction | 2.5 years after last patient enrollment |
| Cardiovascular death or myocardial infarction | 2.5 years after last patient enrollment |
| Myocardial infarction or hospitalization for heart failure | 2.5 years after last patient enrollment |
| Any revascularization | 2.5 years after last patient enrollment |
| Myocardial infarction or any revascularization | 2.5 years after last patient enrollment |
| Cardiovascular death, myocardial infarction, or hospitalization for heart failure | 2.5 years after last patient enrollment |
| Cardiovascular death, myocardial infarction, or any revascularization | 2.5 years after last patient enrollment |
| left ventricle ejection fraction | changes in left ventricle ejection fraction | at 2 years |
| N-terminal pro-brain natriuretic peptide (NT-proBNP) | changes in NT-proBNP | 2.5 years after last patient enrollment |
| Atrial fibrillation occurrence | 2.5 years after last patient enrollment |
| Medical cost | The medical expenses related to heart problems during the follow-up | at 2 years |
| PROMIS 29 | PROMIS 29 is composed of a total of 29 questions, and questions are composed of domains for physical function, anxiety, depression, sleep, social function, participation availability, and pain. | 2.5 years after last patient enrollment |
| Adverse effects related with β-blocker | 2.5 years after last patient enrollment |
| Rate of Hospitalization for cardiovascular causes | Rate of Hospitalization for cardiovascular causes | 2.5 years after last patient enrollment |
| Rate of Stroke | Rate of ischemic or hemorrhagic stroke | 2.5 years after last patient enrollment |
| Derived |
| 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |