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Long-term Beta-blocker Therapy After Acute Myocardial Infarction (SMART-DECISION)

Primary Purpose

Myocardial Infarction

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Discontinuation of β-blocker

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

β-blocker discontinuation arm

β-blocker maintenance arm

Arm Description

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

Continuation of β-blocker therapy after acute myocardial infarction

Outcomes

Primary Outcome Measures

Major adverse cardiac events

a composite of all-cause death, myocardial infarction, hospitalization for heart failure

Secondary Outcome Measures

All-cause death

Cardiac death

Myocardial infarction

Any hospitalization

Hospitalization for heart failure

Hospitalization for acute coronary syndrome

All-cause death or myocardial infarction

Cardiac death or myocardial infarction

Myocardial infarction or hospitalization for heart failure

Any revascularization

Myocardial infarction or any revascularization

Cardiac death, myocardial infarction, or any revascularization

Left ventricle ejection fraction

N-terminal pro-brain natriuretic peptide (NT-proBNP)

Atrial fibrillation occurrence

Medical cost

The medical expenses related to heart problems during the follow-up

PROMIS 29

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

Full Information

NCT ID

NCT04769362

First Posted

February 21, 2021

Last Updated

February 1, 2023

Sponsor

Samsung Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04769362

Brief Title

Long-term Beta-blocker Therapy After Acute Myocardial Infarction

Acronym

SMART-DECISION

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 4, 2021 (Actual)

Primary Completion Date

March 20, 2026 (Anticipated)

Study Completion Date

March 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

β-blocker discontinuation arm

Arm Type

Experimental

Arm Description

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

Arm Title

β-blocker maintenance arm

Arm Type

No Intervention

Arm Description

Continuation of β-blocker therapy after acute myocardial infarction

Intervention Type

Drug

Intervention Name(s)

Discontinuation of β-blocker

Intervention Description

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

Primary Outcome Measure Information:

Title

Major adverse cardiac events

Description

a composite of all-cause death, myocardial infarction, hospitalization for heart failure

Time Frame

2 years after last patient enrollment

Secondary Outcome Measure Information:

Title

All-cause death

Time Frame

2 years after last patient enrollment

Title

Cardiac death

Time Frame

2 years after last patient enrollment

Title

Myocardial infarction

Time Frame

2 years after last patient enrollment

Title

Any hospitalization

Time Frame

2 years after last patient enrollment

Title

Hospitalization for heart failure

Time Frame

2 years after last patient enrollment

Title

Hospitalization for acute coronary syndrome

Time Frame

2 years after last patient enrollment

Title

All-cause death or myocardial infarction

Time Frame

2 years after last patient enrollment

Title

Cardiac death or myocardial infarction

Time Frame

2 years after last patient enrollment

Title

Myocardial infarction or hospitalization for heart failure

Time Frame

2 years after last patient enrollment

Title

Any revascularization

Time Frame

at 2 years after randomization

Title

Myocardial infarction or any revascularization

Time Frame

2 years after last patient enrollment

Title

Cardiac death, myocardial infarction, or any revascularization

Time Frame

2 years after last patient enrollment

Title

Left ventricle ejection fraction

Time Frame

2 years after last patient enrollment

Title

N-terminal pro-brain natriuretic peptide (NT-proBNP)

Time Frame

at 2 years

Title

Atrial fibrillation occurrence

Time Frame

2 years after last patient enrollment

Title

Medical cost

Description

The medical expenses related to heart problems during the follow-up

Time Frame

2 years after last patient enrollment

Title

PROMIS 29

Description

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.

Time Frame

2 years after last patient enrollment

Title

Adverse effects related with β-blocker

Time Frame

2 years after last patient enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joo-Yong Hahn, MD,PhD

Phone

82-2-3410-6653

jyhahn@skku.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ki Hong Choi

Phone

82-2-3410-3419

cardiokh@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo-Yong Hahn, MD,PhD

Organizational Affiliation

Samsung Medical Center, Sungkyunkwan University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joo-Yong Hahn, MD, PhD

Phone

82-2-3410-6653

ichjy1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

Learn more about this trial

Long-term Beta-blocker Therapy After Acute Myocardial Infarction

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