Myocardial InfarctionPhase 4SMART-DECISIONNCT04769362
Long-term Beta-blocker Therapy After Acute Myocardial Infarction
A Phase 4 study testing Discontinuation of β-blocker in people with Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Discontinuation of β-blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,540 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 May 2021to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 19 years of age.
- 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.
Who cannot join
- Subject whose left ventricle ejection fraction was less than 40% from echocardiography performed after acute myocardial infarction or who have never received echocardiography.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Joo-Yong Hahn, MD, PhD, 82-2-3410-6653, ichjy1@gmail.com
About this study
Official title: Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial
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.
Read the detailed description
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.
- Conditions
- Myocardial Infarction
- Being tested
- Discontinuation of β-blocker
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of β-blockerDrug
Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| β-blocker discontinuation arm | Experimental | Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction Receives: Drug: Discontinuation of β-blocker |
| β-blocker maintenance arm | No intervention | Continuation of β-blocker therapy after acute myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
a composite of all-cause death, myocardial infarction, hospitalization for heart failure
Measured: 2.5 years after last patient enrollment
Secondary outcomes (21)
All-cause death
Measured: 2.5 years after last patient enrollment
Cardiovascular death
Measured: 2.5 years after last patient enrollment
Myocardial infarction
Measured: 2.5 years after last patient enrollment
Any hospitalization
Measured: 2.5 years after last patient enrollment
Hospitalization for heart failure
Measured: 2.5 years after last patient enrollment
Hospitalization for acute coronary syndrome
Measured: 2.5 years after last patient enrollment
All-cause death or myocardial infarction
Measured: 2.5 years after last patient enrollment
Cardiovascular death or myocardial infarction
Measured: 2.5 years after last patient enrollment
Myocardial infarction or hospitalization for heart failure
Measured: 2.5 years after last patient enrollment
Any revascularization
Measured: 2.5 years after last patient enrollment
Myocardial infarction or any revascularization
Measured: 2.5 years after last patient enrollment
Cardiovascular death, myocardial infarction, or hospitalization for heart failure
Measured: 2.5 years after last patient enrollment
Cardiovascular death, myocardial infarction, or any revascularization
Measured: 2.5 years after last patient enrollment
left ventricle ejection fraction
changes in left ventricle ejection fraction
Measured: at 2 years
N-terminal pro-brain natriuretic peptide (NT-proBNP)
changes in NT-proBNP
Measured: 2.5 years after last patient enrollment
Atrial fibrillation occurrence
Measured: 2.5 years after last patient enrollment
Medical cost
The medical expenses related to heart problems during the follow-up
Measured: 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.
Measured: 2.5 years after last patient enrollment
Adverse effects related with β-blocker
Measured: 2.5 years after last patient enrollment
Rate of Hospitalization for cardiovascular causes
Rate of Hospitalization for cardiovascular causes
Measured: 2.5 years after last patient enrollment
Rate of Stroke
Rate of ischemic or hemorrhagic stroke
Measured: 2.5 years after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start4 May 2021
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Gyeongsang National University Hospital, Kyung Hee University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Sejong General Hospital, Seoul National University Bundang Hospital, Samsung Changwon Hospital, Saint Vincent's Hospital, Korea, Presbyterian medical center, Wonkwang University Hospital, Wonju Severance Christian Hospital, Ewha Womans University Seoul Hospital, Inje University Ilsan Paik Hospital, Chonbuk National University Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chosun University Hospital, Chungbuk National University Hospital, Chungnam National University Hospital
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769362
- Sponsor's protocol ID
- SMC202010176
- Acronym
- SMART-DECISION
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
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.
PubMed 41910427Choi 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.
PubMed 39645270
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04769362
- Acronym / sponsor ID
- SMART-DECISION / SMC202010176
- Conditions
- Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,540 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Gyeongsang National University Hospital, Kyung Hee University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Sejong General Hospital, Seoul National University Bundang Hospital, Samsung Changwon Hospital, Saint Vincent's Hospital, Korea, Presbyterian medical center, Wonkwang University Hospital, Wonju Severance Christian Hospital, Ewha Womans University Seoul Hospital, Inje University Ilsan Paik Hospital, Chonbuk National University Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chosun University Hospital, Chungbuk National University Hospital, Chungnam National University Hospital
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| β-blocker discontinuation arm | Experimental | Drug: Discontinuation of β-blockerDiscontinuation 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be at least 19 years of age.
- 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.
Key exclusion criteria (6 listed)
- Subject whose left ventricle ejection fraction was less than 40% from echocardiography performed after acute myocardial infarction or who have never received echocardiography.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of β-blockerDiscontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction | Drug | β-blocker discontinuation arm |
Primary outcome
Major adverse cardiac events
Time frame: 2.5 years after last patient enrollment
a composite of all-cause death, myocardial infarction, hospitalization for heart failure
21 secondary outcomes
All-cause death
Time frame: 2.5 years after last patient enrollment
Cardiovascular death
Time frame: 2.5 years after last patient enrollment
Myocardial infarction
Time frame: 2.5 years after last patient enrollment
Any hospitalization
Time frame: 2.5 years after last patient enrollment
Hospitalization for heart failure
Time frame: 2.5 years after last patient enrollment
Hospitalization for acute coronary syndrome
Time frame: 2.5 years after last patient enrollment
All-cause death or myocardial infarction
Time frame: 2.5 years after last patient enrollment
Cardiovascular death or myocardial infarction
Time frame: 2.5 years after last patient enrollment
Myocardial infarction or hospitalization for heart failure
Time frame: 2.5 years after last patient enrollment
Any revascularization
Time frame: 2.5 years after last patient enrollment
Myocardial infarction or any revascularization
Time frame: 2.5 years after last patient enrollment
Cardiovascular death, myocardial infarction, or hospitalization for heart failure
Time frame: 2.5 years after last patient enrollment
Cardiovascular death, myocardial infarction, or any revascularization
Time frame: 2.5 years after last patient enrollment
left ventricle ejection fraction
Time frame: at 2 years
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 2.5 years after last patient enrollment
Atrial fibrillation occurrence
Time frame: 2.5 years after last patient enrollment
Medical cost
Time frame: at 2 years
PROMIS 29
Time frame: 2.5 years after last patient enrollment
Adverse effects related with β-blocker
Time frame: 2.5 years after last patient enrollment
Rate of Hospitalization for cardiovascular causes
Time frame: 2.5 years after last patient enrollment
Rate of Stroke
Time frame: 2.5 years after last patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 41910427Choi 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.
- Derived from this study: PubMed 39645270Choi 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joo-Yong Hahn, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discontinuation of β-blocker in people with Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo-Yong Hahn, MD,PhD (82-2-3410-6653, jyhahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 2.5 years after last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.