Myocardial Infarction
Conditions
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.
Interventions
DRUGDiscontinuation of β-blocker
Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
Sponsors
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
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 2.5 years after last patient enrollment | a composite of all-cause death, myocardial infarction, hospitalization for heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Hospitalization for acute coronary syndrome | 2.5 years after last patient enrollment | — |
| All-cause death or myocardial infarction | 2.5 years after last patient enrollment | — |
| Cardiovascular death or myocardial infarction | 2.5 years after last patient enrollment | — |
| Myocardial infarction or hospitalization for heart failure | 2.5 years after last patient enrollment | — |
| Any revascularization | 2.5 years after last patient enrollment | — |
| Cardiovascular death, myocardial infarction, or hospitalization for heart failure | 2.5 years after last patient enrollment | — |
| Cardiovascular death, myocardial infarction, or any revascularization | 2.5 years after last patient enrollment | — |
| left ventricle ejection fraction | at 2 years | changes in left ventricle ejection fraction |
| N-terminal pro-brain natriuretic peptide (NT-proBNP) | 2.5 years after last patient enrollment | changes in NT-proBNP |
| Atrial fibrillation occurrence | 2.5 years after last patient enrollment | — |
| Medical cost | at 2 years | The medical expenses related to heart problems during the follow-up |
| PROMIS 29 | 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. |
| Adverse effects related with β-blocker | 2.5 years after last patient enrollment | — |
| Rate of Hospitalization for cardiovascular causes | 2.5 years after last patient enrollment | Rate of Hospitalization for cardiovascular causes |
| Rate of Stroke | 2.5 years after last patient enrollment | Rate of ischemic or hemorrhagic stroke |
| Myocardial infarction or any revascularization | 2.5 years after last patient enrollment | — |
Countries
South Korea
Contacts
Primary ContactJoo-Yong Hahn, MD,PhD
Backup ContactKi Hong Choi
Outcome results
None listed