Long-term Beta-blocker Therapy After Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

— SMART-DECISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769362
• Other study ID #: SMC202010176
• Status: Recruiting
• Phase: Phase 4
• Start date: May 4, 2021
• Est. completion date: March 20, 2026

Study information

• Verified date: December 2023
• Source: Samsung Medical Center
• Contact: Joo-Yong Hahn, MD,PhD
• Phone: 82-2-3410-6653
• Email: jyhahn[@]skku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2540
• Est. completion date: March 20, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Subject must be at least 19 years of age.

• Subject who have been continuing ß-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 ß-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 ß-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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Discontinuation of ß-blocker
Discontinuation of ß-blocker after at least 1 year of ß-blocker therapy after acute myocardial infarction

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (21)

Lead Sponsor

Collaborator

Samsung Medical Center

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	a composite of all-cause death, myocardial infarction, hospitalization for heart failure	2.5 years after last patient enrollment
Secondary	All-cause death		2.5 years after last patient enrollment
Secondary	Cardiac death		2.5 years after last patient enrollment
Secondary	Myocardial infarction		2.5 years after last patient enrollment
Secondary	Any hospitalization		2.5 years after last patient enrollment
Secondary	Hospitalization for heart failure		2.5 years after last patient enrollment
Secondary	Hospitalization for acute coronary syndrome		2.5 years after last patient enrollment
Secondary	All-cause death or myocardial infarction		2.5 years after last patient enrollment
Secondary	Cardiac death or myocardial infarction		2.5 years after last patient enrollment
Secondary	Myocardial infarction or hospitalization for heart failure		2.5 years after last patient enrollment
Secondary	Any revascularization		2.5 years after last patient enrollment
Secondary	Myocardial infarction or any revascularization		2.5 years after last patient enrollment
Secondary	Cardiac death, myocardial infarction, or any revascularization		2.5 years after last patient enrollment
Secondary	Left ventricle ejection fraction		2.5 years after last patient enrollment
Secondary	N-terminal pro-brain natriuretic peptide (NT-proBNP)		at 2 years
Secondary	Atrial fibrillation occurrence		2.5 years after last patient enrollment
Secondary	Medical cost	The medical expenses related to heart problems during the follow-up	2.5 years after last patient enrollment
Secondary	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.	at 2 years
Secondary	Adverse effects related with ß-blocker		2.5 years after last patient enrollment