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临床试验/EUCTR2011-001795-19-DE
EUCTR2011-001795-19-DE进行中(未招募)1 期

STATIN RECAPTURE THERAPY BEFORE CORONARY ARTERY BYPASS GRAFTING (ACRONYM: START-CABG TRIAL) - StaRT-CABG

niversity of Cologne0 个研究点目标入组 2,630 人开始时间: 2012年7月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
2,630

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

  • Patients on long term statin treatment (=30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo’s) revascularisation procedures
  • Stable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
  • Age = 18 years
  • Written informed consent
  • 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 1315
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1315

排除标准

  • Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
  • Acute ST-segment-elevation myocardial infarction (STEMI)
  • Or NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 24 hours from hospital admission
  • History of atrial fibrillation or muscle disease (myopathy)
  • Current renal (creatinine >2 mg/dL (180 µmol/L), dialysis, kidney transplant)) or hepatic dysfunction (AST or ALT >3x ULN, liver transplant or neoplasm)
  • Inability of oral drug intake

研究者

发起方
niversity of Cologne

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