Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Trials. 2023 Oct 6;24(1):645. doi: 10.1186/s13063-023-07682-6.
Patients with acute myocardial infarction are at greater risk for chronic heart failure and mortality. Currently, there is limited evidence supporting the beneficial effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular outcomes in non-diabetic patients with reduced left ventricular ejection fraction following acute myocardial infarction. Furthermore, the clinical effects of the combination of standard-dose sodium-glucose cotransporter-2 inhibitors with colchicine and high-dose sodium-glucose cotransporter-2 inhibitors in this setting have not been evaluated yet.
A prospective, double-blinded, parallel-group, placebo control randomized trial will be carried out at Shahid Madani Heart Center, the largest teaching referral hospital for cardiovascular diseases, affiliated with Tabriz University of Medical Sciences. A total of 105 patients with reduced left ventricular ejection fraction (≤ 40%) following the first episode of ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention with stent insertion will be randomized 1:1:1 to receive empagliflozin 10 mg daily, a combination of empagliflozin 10 mg daily and colchicine 0.5 mg twice daily, or empagliflozin 25 mg daily for 12 weeks. The primary outcomes are changes in the New York Heart Association functional classification and high-sensitivity C-reactive protein from the randomization through week 4 and week 12.
The present study will be the first trial to evaluate the efficacy and safety of early treatment with the combination of standard-dose empagliflozin and colchicine as well as high-dose empagliflozin in non-diabetic patients with reduced left ventricular ejection fraction following ST-elevation myocardial infarction. The results of this research will represent a significant step forward in the treatment of patients with acute myocardial infarction.
Clinical trial ID: IRCT20111206008307N39. Registration date: 27 October 2022.
急性心肌梗死患者发生慢性心力衰竭和死亡的风险更高。目前，仅有有限的证据支持钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）对急性心肌梗死后左心室射血分数降低的非糖尿病患者心血管结局的有益作用。此外，在这种情况下，标准剂量 SGLT2i 联合秋水仙碱和高剂量 SGLT2i 的联合治疗的临床效果尚未得到评估。
一项前瞻性、双盲、平行组、安慰剂对照随机试验将在沙希德·马丹尼心脏中心进行，该中心是隶属于大不里士医科大学的最大心血管疾病教学转诊医院。共有 105 例首次发生 ST 段抬高型心肌梗死并接受经皮冠状动脉介入治疗置入支架的患者，随机分为 1:1:1 三组，分别接受恩格列净 10mg 每日一次、恩格列净 10mg 每日一次联合秋水仙碱 0.5mg 每日两次或恩格列净 25mg 每日一次治疗 12 周。主要结局是从随机分组到第 4 周和第 12 周时纽约心脏协会功能分级和高敏 C 反应蛋白的变化。
本研究将是首个评估标准剂量恩格列净联合秋水仙碱和高剂量恩格列净早期治疗 ST 段抬高型心肌梗死后左心室射血分数降低的非糖尿病患者的疗效和安全性的试验。该研究的结果将是急性心肌梗死患者治疗的一个重要进展。
临床试验注册号：IRCT20111206008307N39。注册日期：2022 年 10 月 27 日。
