Effects of Dapagliflozin on Inflammatory Factorslevel and Prognosis in Type 2 Diabetes With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- MACE events
研究概览
简要总结
Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF[1]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality[2]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo.
- Faiez Zannad, João Pedro Ferreira, Stuart J Pocock et el. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829.
- Cai-Yan Zou, Xue-Kui Liu, Yi-Quan Sang et el. Effects of SGLT2 inhibitors on cardiovascular outcomes and mortality in type 2 diabetes: A meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18245.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
- •Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
排除标准
- •Patients diagnosed with Type 1 Diabetes Mellitus.
- •Patients with renal dysfunction. (GFR<90mmol/L).
- •Patients who have recently undergone immunosuppressive therapy.
- •Patients with a history of recurrent urinary tract infections.
- •Patients who are known to be allergic to SGLT-2 inhibitors.
- •Patients who are hemodynamically unstable.
- •Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
- •Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
- •Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
- •Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).
研究组 & 干预措施
Intervention Group
Dapagliflozin 10 mg every 24 hours for 12 months
干预措施: Dapagliflozin 10mg/Tab (Drug)
Control Group
AMI standard therapy for 12 months
干预措施: control group (Drug)
结局指标
主要结局
MACE events
时间窗: 12 months
To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time.
Post-infarction angina
时间窗: 12 months
Evaluate the post-infarction angina occurence in both groups
IL-6
时间窗: baseline, 1 month, 3 month, 6 month, 12 month
Serum IL-6 level
The rate of heart failure occurrence
时间窗: 12 months
Assess the rate of new-onset heart failure during the study follow-up.
次要结局
- IL-1β(baseline, 1 month, 3 month, 6 month, 12 month)
- hs-CRP(baseline, 1 month, 3 month, 6 month, 12 month)