Long-term Beta-blocker Therapy After Acute Myocardial Infarction
NCT ID: NCT04769362
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2540 participants
INTERVENTIONAL
2021-05-04
2026-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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β-blocker discontinuation arm
Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction
Discontinuation of β-blocker
Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
β-blocker maintenance arm
Continuation of β-blocker therapy after acute myocardial infarction
No interventions assigned to this group
Interventions
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Discontinuation of β-blocker
Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
Eligibility Criteria
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Inclusion Criteria
* Subject who have been continuing β-blocker therapy for at least 1 year after acute myocardial infarction regardless of the time of diagnosis
* Subject is able to verbally confirm understandings of risks and benefits of this trial, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria
* Treatment history of heart failure
* Contraindication to β-blocker therapy (history of symptomatic bronchial asthma or chronic obstructive pulmonary disease, 2nd or 3rd degree AV block, cardiac pacemaker implantation, or other cases where β-blocker cannot be used under the judgment of the clinician)
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* History of atrial fibrillation
* Pregnancy or breast feeding
19 Years
ALL
No
Sponsors
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Kangbuk Samsung Hospital
OTHER
Gyeongsang National University Hospital
OTHER
Kyung Hee University Hospital
OTHER
Keimyung University Dongsan Medical Center
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
Samsung Medical Center
OTHER
Responsible Party
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Joo-Yong Hahn
MD, PhD, Division of Cardiology, Department of Medicine
Principal Investigators
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Joo-Yong Hahn, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, Sungkyunkwan University School of Medicine
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Joo-Yong Hahn, MD, PhD
Role: primary
References
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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.
Other Identifiers
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SMC202010176
Identifier Type: -
Identifier Source: org_study_id