Evaluating the effects of stopping beta-blockers after heart attack
Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial
This study is testing whether stopping beta-blocker medication after a heart attack is just as good for recovery as continuing to take it for people who don't have heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2540 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04769362 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if stopping beta-blocker therapy after at least one year is as effective as continuing the treatment in patients who have experienced an acute myocardial infarction but do not have heart failure or left ventricular systolic dysfunction. It is a prospective, open-label, randomized, multicenter, noninferiority trial designed to provide clarity on the optimal duration of beta-blocker therapy in this patient population. The trial will compare outcomes between those who discontinue beta-blockers and those who continue the therapy, addressing a significant gap in current clinical guidelines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who have been on beta-blocker therapy for at least one year following an acute myocardial infarction without heart failure or left ventricular dysfunction.
Not a fit: Patients with a history of heart failure, significant left ventricular dysfunction, or contraindications to beta-blocker therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help refine treatment protocols for patients recovering from a heart attack, potentially reducing unnecessary medication use.
How similar studies have performed: Previous studies on long-term beta-blocker therapy have been limited, making this trial's approach novel and potentially groundbreaking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Joo-Yong Hahn, MD,PhD — Samsung Medical Center
- Study coordinator: Joo-Yong Hahn, MD,PhD
- Email: jyhahn@skku.edu
- Phone: 82-2-3410-6653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.