Long-term Beta-blocker Therapy After Acute Myocardial Infarction

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Major adverse cardiac events [Срок оценки: 2.5 years after last patient enrollment]

Вторичные конечные точки (12)

• All-cause death [Срок оценки: 2.5 years after last patient enrollment]
• Cardiovascular death [Срок оценки: 2.5 years after last patient enrollment]
• Myocardial infarction [Срок оценки: 2.5 years after last patient enrollment]
• Any hospitalization [Срок оценки: 2.5 years after last patient enrollment]
• Hospitalization for heart failure [Срок оценки: 2.5 years after last patient enrollment]
• Hospitalization for acute coronary syndrome [Срок оценки: 2.5 years after last patient enrollment]
• All-cause death or myocardial infarction [Срок оценки: 2.5 years after last patient enrollment]
• Cardiovascular death or myocardial infarction [Срок оценки: 2.5 years after last patient enrollment]
• Myocardial infarction or hospitalization for heart failure [Срок оценки: 2.5 years after last patient enrollment]
• Any revascularization [Срок оценки: 2.5 years after last patient enrollment]
• Myocardial infarction or any revascularization [Срок оценки: 2.5 years after last patient enrollment]
• Cardiovascular death, myocardial infarction, or hospitalization for heart failure [Срок оценки: 2.5 years after last patient enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Samsung Medical Center — Seoul

Публикации

• 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 Myocard PMID 41910427
• 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 PMID 39645270

Идентификаторы

NCT: NCT04769362 · SMC202010176

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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