跳至主要内容
临床试验/EUCTR2009-013622-17-IT
EUCTR2009-013622-17-IT进行中(未招募)不适用

ROSUVASTATIN FOR REDUCTION OF MYOCARDIAL DAMAGE AND SYSTEMIC INFLAMMATION DURING CORONARY ANGIOPLASTY - The REMEDY Study - ND

CARDIOLOGIA UNIVERSITARIA - OSPEDALE CLINICIZZATO SS. ANNUNZIATA - VIA DEI VESTINI - 66013 CHIETI0 个研究点开始时间: 2009年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion criteria will be the presence of suspected CAD for which an indication to PCI is given. This study will therefore include both patients with stable CAD, and stable post-acute coronary syndromes (ACS), both with ST-segment elevation (STEMI) and without ST-segment elevation (NSTE-ACS) patients, provided that markers of myocardial necrosis (CK-MB, troponins) are stabilized (i.e., with variations <20% in two consecutive measurements obtained at ≥6 h time distance before PCI, according to the universal definition of peri-procedural myocardial infarction43). Randomization will be performed independent of the knowledge of coronary anatomy. Outcome evaluation will be however primarily performed on patients randomized and receiving a PCI.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion criteria will be:
  • oany previously known increase in liver enzymes (AST, ALT) ascribed to liver dysfunction at baseline;
  • ohistory of liver toxicity or myopathy on previous treatment with statins;
  • oleft ventricular ejection fraction <30%;
  • orenal insufficiency, with creatinine >2 mg/dL at baseline;
  • opregnant women.

研究者

发起方
CARDIOLOGIA UNIVERSITARIA - OSPEDALE CLINICIZZATO SS. ANNUNZIATA - VIA DEI VESTINI - 66013 CHIETI

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