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

Who is this study for? Patients with Myocardial Infarction
What treatments are being studied? Discontinuation of ?-blocker
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Joo-Yong Hahn, MD,PhD
jyhahn@skku.edu
82-2-3410-6653
Backup
Ki Hong Choi
cardiokh@gmail.com
82-2-3410-3419
Time Frame
Start Date: 2021-05-04
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 2540
Treatments
Experimental: β-blocker discontinuation arm
Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction
No_intervention: β-blocker maintenance arm
Continuation of β-blocker therapy after acute myocardial infarction
Related Therapeutic Areas
Sponsors
Collaborators: Seoul National University Bundang Hospital, Samsung Changwon Hospital, Wonkwang University Hospital, Chonnam National University Hospital, Kangbuk Samsung Hospital, Kyung Hee University Hospital, Gyeongsang National University Hospital, Chungbuk National University Hospital, Ewha Womans University Seoul Hospital, Chungnam National University Hospital, Keimyung University Dongsan Medical Center, Chonbuk National University Hospital, Presbyterian medical center, Saint Vincent's Hospital, Korea, Sejong General Hospital, Chosun University Hospital, Korea University Anam Hospital, Wonju Severance Christian Hospital, Jeju National University Hospital, Inje University Ilsan Paik Hospital
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov