Overview

Long-term Beta-blocker Therapy After Acute Myocardial Infarction

Status:
Not yet recruiting
Trial end date:
2026-03-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Collaborators:
Chonbuk National University Hospital
Chonnam National University Hospital
Chosun University Hospital
Chungbuk National University Hospital
Chungnam National University Hospital
Ewha Womans University
Ewha Womans University Seoul Hospital
Gyeongsang National University Hospital
Inje University
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
Treatments:
Adrenergic beta-Antagonists
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

- Severe renal dysfunction (creatinine clearance < 30 ml/min/1.73 m2)