Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CRP change
研究概览
简要总结
Empagliflozin is a drug given to lower glucose. It is used in the treatment of diabetes. However, it was shown to improve symptoms and survival of patients who are suffering from heart failure. The exact mechanism of this effect is currently not clearly understood.
He hypothesize that empagliflozin has other properties than glucose lowering, that can explain its efficacy. One of these properties, is an anti-inflammatory effect.
To document this, we are using a model of inflammation following percutaneous coronary scenting. We know that patients who get a stent will develop inflammation following stenting. This is documenting by a higher level of C-Reactive Protein 24 hours after the procedure.
Patients who will participate in the study, will receive empagliflozin or a placebo tablet for 3 days prior to the revascularisation procedure. CRP and other inflammatory markers will be measured before intervention and 24 hours later. The goal is to demonstrate a lower rise in CRP following intervention in patients treated with empagliflozin vs. those who have received a placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery
排除标准
- •• Patients who have been taking an SGLT-2 inhibitor during the last month
- •Patients who are receiving any anti-inflammatory medication: immunosuppressor, steroids, NSAID…
- •Patients who have underlying inflammatory conditions such as rheumatic arthritis, infection, active malignancy
- •Patients with an acute coronary syndrome within the last month
- •Intervention on a restenotic lesion or lesion in a saphenous vein graft
- •Creatinine clearance less than 30 mL/min
- •Patients who are treated with devices other than balloons and stents (lithotripsy, rotational atherectomy…)
研究组 & 干预措施
empagliflozin
Patients who will receive empagliflozin
干预措施: Empagliflozin (SGLT2i) (Drug)
Placebo
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
CRP change
时间窗: baseline and 18-24 hours after pci
High sensitivity CRP will be measured immediately before and 18-24 hours after PCI
次要结局
未报告次要终点
研究者
Rabih Azar
Professor of Medicine
Hotel Dieu de France Hospital