Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

2,540

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started May 2021

Longer than P75 for phase_4

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

February 21, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

May 4, 2021

Completed

4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

February 21, 2021

Last Update Submit

December 21, 2025

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

Major adverse cardiac events
a composite of all-cause death, myocardial infarction, hospitalization for heart failure
2.5 years after last patient enrollment

Secondary Outcomes (21)

All-cause death
2.5 years after last patient enrollment
Cardiovascular death
2.5 years after last patient enrollment
Myocardial infarction
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
+16 more secondary outcomes

Study Arms (2)

β-blocker discontinuation arm

EXPERIMENTAL

Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction

Drug: Discontinuation of β-blocker

β-blocker maintenance arm

NO INTERVENTION

Continuation of β-blocker therapy after acute myocardial infarction

Interventions

Discontinuation of β-blockerDRUG

Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction

β-blocker discontinuation arm

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (2)

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 Mar 30. doi: 10.1056/NEJMoa2601005. Online ahead of print.
PMID: 41910427DERIVED
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.
PMID: 39645270DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

Joo-Yong Hahn, MD,PhD
Samsung Medical Center, Sungkyunkwan University School of Medicine
PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo-Yong Hahn, MD,PhD

CONTACT

82-2-3410-6653 jyhahn@skku.edu

Ki Hong Choi

CONTACT

82-2-3410-3419 cardiokh@gmail.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD, Division of Cardiology, Department of Medicine

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

May 4, 2021

Primary Completion

January 31, 2026

Study Completion

March 31, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing: Will share

Locations

KR(1)

Long-term Beta-blocker Therapy After Acute Myocardial Infarction

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (21)

Study Arms (2)

β-blocker discontinuation arm

β-blocker maintenance arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (21)

Study Arms (2)

β-blocker discontinuation arm

β-blocker maintenance arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations