NCT04769362 Long-term Beta-blocker Therapy After Acute Myocardial Infarction
| NCT ID | NCT04769362 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samsung Medical Center |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,540 participants |
| Start Date | 2021-05-04 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,540 participants in total. It began in 2021-05-04 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Joo-Yong Hahn, MD,PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT04769362 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04769362 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04769362 currently recruiting?
Yes, NCT04769362 is actively recruiting participants. Contact the research team at jyhahn@skku.edu for enrollment information.
Where is the NCT04769362 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT04769362 clinical trial?
NCT04769362 is sponsored by Samsung Medical Center. The principal investigator is Joo-Yong Hahn, MD,PhD at Samsung Medical Center. The trial plans to enroll 2,540 participants.