RecruitingPhase 4NCT04769362

Long-term Beta-blocker Therapy After Acute Myocardial Infarction

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


Sponsor

Samsung Medical Center

Enrollment

2,540 participants

Start Date

May 4, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

DRUGDiscontinuation of β-blocker

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


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT04769362


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