SGLT-2 Inhibitors in Prevention of Post-procedural Renal and Cardiovascular Complications aFter PCI Among Patients With Diabetes Mellitus and Coronary Artery Disease: a Prospective, Randomized, Pilot Study (SAFE-PCI)
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- NGAL values in pre-specified periods
研究概览
简要总结
Patients with type 2 diabetes mellitus (DM) have higher risk of major cardiovascular events (MACE) and renal disfunction. The Sodium-glucose cotransporter-2 inhibitors (iSGLT2) reduces hyperglycemia in patients with type 2 DM and have multiple metabolic effects, lowering primary composite cardiovascular outcomes and progression to renal failure. 25% of patients with Stable Ischemic Heart Disease (SIHD) undergoing PCI are diabetics being one of the most prevalent and important risk factors for the development of contrast induced nephropathy (CIN). The occurence of CIN is associated with higher rates of death, loss of renal function, necessity of dialysis and increase of health care costs. In this pilot study we sought to evaluate if the iSGLT2 would prevent periprocedural complications - such as periprocedural CIN and MI - in type 2 DM patients undergoing PCI through the assessment of renal and myocardial biomarkers
详细描述
- Prospective, unblinded, randomized (1:1), single-center pilot study of 40 patients allocated to one of the treatment arms (OMT + empaglifozin or OMT). Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms
- The study population will be composed of patients with type II diabetes mellitus and coronary artery disease (CAD) suitable for PCI of one or more coronary vessels
- After discharge, all subjects will be clinically followed-up during hospitalization and for 30 days after PCI.
- Unless contra-indicated, all patients will receive intravenous hydration during 12 hours pre- and 12 hours post-PCI. Saline (NaCl 0.9%) infusion is recommended at a dose of 1 ml / kg body weight per hour and reduced to 0.5 ml/kg/h for those at high risk of volume overload (e.g. reduced left ventricular function or overt heart failure). All nephrotoxic drugs will be suspended at least 24 hours before the procedure.
- Operators will be strongly recommended to follow strict strategies to reduce the total volume of contrast for all patients
- All percutaneous procedures will be performed using non-ionic, low-osmolar or iso-osmolar, iodine-based contrast media
- The study groups will be compared according to the intention-to-treat principle. Categorical variables will be compared by Fisher's exact testing and continuous variables by Student's T testing. Time-dependent events will be estimated by the Kaplan-Meier method and compared by Hazards Cox modeling or log-rank test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age ≥ 18 years
- •Type II Diabetes mellitus
- •Finding of obstructive coronary artery disease (≥50% stenosis in major epicardial vessel) and clinical indication of percutaneous coronary intervention.(PCI)
- •Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
- •Participant is willing to give written informed consent
排除标准
- •Estimated glomerular filtration rate (eGFR) < 30mL/min/1,73m2 or dialysis
- •Inability to comply with the protocol
- •Urgent need for PCI
- •Acute coronary syndrome within the previous 30 days
- •Use of iodinated contrast or other nephrotoxic agents < 7 days
- •Angina after coronary bypass surgery
- •Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
- •Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- •Pregnancy
研究组 & 干预措施
empagliflozin + OMT
empagliflozin 25mg - Daily - at least 15 days before the PCI procedure OMT - Optimized Medical Therapy - conventional drug therapy with oral antidiabetics and/or insulin plus use of anti-platelet, anti-hypertensive and lipid-lowering agents necessary to obtain adequate values for pressure, lipid control and glycemia, in accordance with international guidelines and protocols. Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms
干预措施: empagliflozin 25 MG (Drug)
结局指标
主要结局
NGAL values in pre-specified periods
时间窗: Day 30
Delta and area under curve
Serum creatinine values in pre-specified periods
时间窗: Day 30
Delta and area under curve
次要结局
- Increase in serum creatinine ≥ 0.3 mg/dl or 50% from the baseline value, within 48 hours after the index procedure(48 hours after PCI)
- Biomarkers elevation ≥10 upper reference limit (URL) for creatine kinase MB (CKMB) and/or ≥70 URL for troponin(24 hours after PCI)
- Myocardial Infarction(Until 30 days)
- Occurrence of definite or probable stent thrombosis(Until 30 days)
- Death From Cardiovascular Causes(Until 30 days)
- Stroke(Until 30 days)
- Hospitalization for Unstable Angina(Until 30 days)
- Death(Until 30 days)
- Bleeding (BARC 3-5)(Until 30 days)
研究者
Carlos Vicente Serrano Jr
MD, PhD
University of Sao Paulo General Hospital