| Autor: |
Jin-Ok Jeong, Juhee Cho, Chang-Hwan Yoon, Sung Gyun Ahn, Cheol Woong Yu, Hyun Kuk Kim, Danbee Kang, Eliseo Guallar, Juwon Kim, Ki Hong Choi, Taek Kyu Park, Jeong Hoon Yang, Young Bin Song, Hyeon-Cheol Gwon, Yong Hwan Park, Jang Hyun Cho, Joo-Yong Hahn, Chang-Wook Nam, Joon-Hyung Doh, Jihoon Kim, Weon Kim, Sung-Ho Her, Eun-Seok Shin, Jin-Yong Hwang, Juhan Kim, Jong Pil Park, Sang Min Kim, Byung-Ryul Cho, Seung-Jae Joo, Jon Suh, Woo Jang, Seong-Hoon Lim, Sang-Rok Lee, Byung Jin Kim, Kyu Tae Park, Joo-Myung Lee, Seung Hyuk Choi |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
BMJ Open, Vol 14, Iss 8 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2044-6055 |
| DOI: |
10.1136/bmjopen-2024-086971 |
| Popis: |
Introduction There is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction.Methods and analysis The SMart Angioplasty Research Team: DEcision on Medical Therapy in Patients with Coronary Artery DIsease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicentre, prospective, open-label, randomised, non-inferiority trial designed to determine whether discontinuing β-blocker therapy after ≥1 year of maintenance in stabilised patients after AMI is non-inferior to continuing it. Patients eligible for participation are those without HF or left ventricular systolic dysfunction (ejection fraction >40%) who have been continuing β-blocker therapy for ≥1 year after AMI. A total of 2540 patients will be randomised 1:1 to continuation of β-blocker therapy or not. Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol or other) and participating centre. The primary study endpoint is a composite of all-cause death, MI and hospitalisation for HF over a median follow-up period of 3.5 years (minimum, 2.5 years; maximum, 4.5 years). Adverse effects related to β-blocker therapy, the occurrence of atrial fibrillation, medical costs and Patient-reported Outcomes Measurement Information system-29 questionnaire responses will also be collected as secondary endpoints.Ethics and dissemination Ethics approval for this study was granted by the Institutional Review Board of Samsung Medical Center (no. 2020-10-176). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.Trial registration number ClinicalTrials.gov, NCT04769362. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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