Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Trials. 2010 Dec 20;11:122. doi: 10.1186/1745-6215-11-122.
Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clearly defined and debatable. Therefore additional prophylactic pretreatments are needed.
METHODS/DESIGN: The present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) routine treatment without sarpogrelate, and (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.
As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.
NCT01165567.
对比剂肾病（CIN）是一种严重的临床问题，与发病率和死亡率增加有关，特别是在慢性肾功能不全患者中。尽管一些药物，包括生理盐水水化，被用于预防这些高危患者的肾功能恶化，但它们的疗效尚未明确，存在争议。因此，需要额外的预防性预处理。
方法/设计：本研究旨在探讨在慢性肾脏病（CKD）患者中，预先使用沙格雷酯对 CIN 发生的影响。将招募 268 名年龄在 20-85 岁之间、临床诊断为 CKD 的参与者。他们将被随机分配到以下两种条件之一：（i）常规治疗无沙格雷酯，和（ii）常规治疗加沙格雷酯（固定剂量 300mg/天）。主要结局是在接受造影剂后 4 周内 CIN 的发生。
截至 2010 年 5 月，尚无评估沙格雷酯预防 CIN 治疗潜力的注册试验。如果沙格雷酯能降低肾功能恶化和 CIN 的发生，将提供一种安全、简便、经济的治疗选择。
NCT01165567。
