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NCT Number: NCT04769362

Long-term Beta-blocker Therapy After Acute Myocardial Infarction

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

Location contact

Joo-Yong Hahn, MD, PhD

CONTACT

[email protected]

82-2-3410-6653

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Discontinuation of β-blocker

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause death

    Time frame: 2.5 years after last patient enrollment

  2. Cardiovascular death

    Time frame: 2.5 years after last patient enrollment

  3. Myocardial infarction

    Time frame: 2.5 years after last patient enrollment

  4. Any hospitalization

    Time frame: 2.5 years after last patient enrollment

  5. Hospitalization for heart failure

    Time frame: 2.5 years after last patient enrollment

  6. Hospitalization for acute coronary syndrome

    Time frame: 2.5 years after last patient enrollment

  7. All-cause death or myocardial infarction

    Time frame: 2.5 years after last patient enrollment

  8. Cardiovascular death or myocardial infarction

    Time frame: 2.5 years after last patient enrollment

  9. Myocardial infarction or hospitalization for heart failure

    Time frame: 2.5 years after last patient enrollment

  10. Any revascularization

    Time frame: 2.5 years after last patient enrollment

  11. Myocardial infarction or any revascularization

    Time frame: 2.5 years after last patient enrollment

  12. Cardiovascular death, myocardial infarction, or hospitalization for heart failure

    Time frame: 2.5 years after last patient enrollment

  13. Cardiovascular death, myocardial infarction, or any revascularization

    Time frame: 2.5 years after last patient enrollment

  14. left ventricle ejection fraction

    Time frame: at 2 years

    changes in left ventricle ejection fraction

  15. N-terminal pro-brain natriuretic peptide (NT-proBNP)

    Time frame: 2.5 years after last patient enrollment

    changes in NT-proBNP

  16. Atrial fibrillation occurrence

    Time frame: 2.5 years after last patient enrollment

  17. Medical cost

    Time frame: at 2 years

    The medical expenses related to heart problems during the follow-up

  18. PROMIS 29

    Time frame: 2.5 years after last patient enrollment

    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.

  19. Adverse effects related with β-blocker

    Time frame: 2.5 years after last patient enrollment

  20. Rate of Hospitalization for cardiovascular causes

    Time frame: 2.5 years after last patient enrollment

    Rate of Hospitalization for cardiovascular causes

  21. Rate of Stroke

    Time frame: 2.5 years after last patient enrollment

    Rate of ischemic or hemorrhagic stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Joo-Yong Hahn, MD,PhD

CONTACT

[email protected]

82-2-3410-6653

Ki Hong Choi

CONTACT

[email protected]

82-2-3410-3419

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Chonbuk National University Hospital
  • Chonnam National University Hospital
  • Chosun University Hospital
  • Chungbuk National University Hospital
  • Chungnam National University Hospital
  • Ewha Womans University Seoul Hospital
  • Gyeongsang National University Hospital
  • Inje University Ilsan Paik Hospital
  • Jeju National University Hospital
  • Kangbuk Samsung Hospital
  • Keimyung University Dongsan Medical Center
  • Korea University Anam Hospital
  • Kyung Hee University Hospital
  • Presbyterian medical center
  • Saint Vincent's Hospital, Korea
  • Samsung Changwon Hospital
  • Sejong General Hospital
  • Seoul National University Bundang Hospital
  • Wonju Severance Christian Hospital
  • Wonkwang University Hospital

Registry information

Official study title

Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial

Acronym: SMART-DECISION

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2021
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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