Clinical trial NCT04769362: Long-term Beta-blocker Therapy After Acute Myocardial Infarction
Official title: Discontinuation of Β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: a Multicenter Randomized Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Kangbuk Samsung Hospital
name: Gyeongsang National University Hospital
name: Kyung Hee University Hospital
name: Keimyung University Dongsan Medical Center
name: Korea University Anam Hospital
name: Sejong General Hospital
name: Seoul National University Bundang Hospital
name: Samsung Changwon Hospital
name: Saint Vincent's Hospital, Korea
name: Presbyterian medical center
name: Wonkwang University Hospital
name: Wonju Severance Christian Hospital
name: Ewha Womans University Seoul Hospital
name: Inje University Ilsan Paik Hospital
name: Chonbuk National University Hospital
name: Chonnam National University Hospital
name: Jeju National University Hospital
name: Chosun University Hospital
name: Chungbuk National University Hospital
name: Chungnam National University Hospital
First posted: 2021-02-24
Enrollment: 2540
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 2.5 years after last patient enrollment
Secondary outcomes:
measure: All-cause death
timeFrame: 2.5 years after last patient enrollment
measure: Cardiovascular death
timeFrame: 2.5 years after last patient enrollment
measure: Myocardial infarction
timeFrame: 2.5 years after last patient enrollment
measure: Any hospitalization
timeFrame: 2.5 years after last patient enrollment
measure: Hospitalization for heart failure
timeFrame: 2.5 years after last patient enrollment
measure: Hospitalization for acute coronary syndrome
timeFrame: 2.5 years after last patient enrollment
measure: All-cause death or myocardial infarction
timeFrame: 2.5 years after last patient enrollment
measure: Cardiovascular death or myocardial infarction
timeFrame: 2.5 years after last patient enrollment
measure: Myocardial infarction or hospitalization for heart failure
timeFrame: 2.5 years after last patient enrollment
measure: Any revascularization
timeFrame: 2.5 years after last patient enrollment
measure: Myocardial infarction or any revascularization
timeFrame: 2.5 years after last patient enrollment
measure: Cardiovascular death, myocardial infarction, or hospitalization for heart failure
timeFrame: 2.5 years after last patient enrollment
measure: Cardiovascular death, myocardial infarction, or any revascularization
timeFrame: 2.5 years after last patient enrollment
measure: left ventricle ejection fraction
timeFrame: at 2 years
measure: N-terminal pro-brain natriuretic peptide (NT-proBNP)
timeFrame: 2.5 years after last patient enrollment
measure: Atrial fibrillation occurrence
timeFrame: 2.5 years after last patient enrollment
measure: Medical cost
timeFrame: at 2 years
measure: PROMIS 29
timeFrame: 2.5 years after last patient enrollment
measure: Adverse effects related with β-blocker
timeFrame: 2.5 years after last patient enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Joo-Yong Hahn, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: