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临床试验/EUCTR2006-006034-18-DE
EUCTR2006-006034-18-DE进行中（未招募）不适用

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTERSTUDY TO EVALUATE THE CARDIOPROTECTIVE EFFECTS OF MC-1 IN PATIENTSUNDERGOING HIGH-RISK CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY - MEND-CABG II

Medicure International Inc.0 个研究点目标入组 3,000 人开始时间: 2007年1月29日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
3,000
研究概览入排标准研究者记录与标识符相似试验

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

  • •Provide informed consent
  • •Patients who are =18 years of age
  • •Male patients, or female patients who are not of childbearing potential or female patients who have had a negative pregnancy test and are practicing adequate contraception
  • •Patients must be scheduled to undergo CABG surgery with planned cardiopulmonary bypass, during routine scheduling times
  • •Patients must be considered at high-risk” for subsequent myocardial complications
  • •defined as meeting TWO OR MORE of the following criteria :
  • •o Age = 65 years
  • •o Current or recent smoker (within the last 6 months)
  • •o History of diabetes mellitus requiring treatment other than diet
  • •o Evidence of left ventricular dysfunction or congestive heart failure
  • •o History of a previous non-disabling stroke, transient ischemic attack, or
  • •carotid endarterectomy
  • •o Urgent CABG intervention defined as the need to stay in the hospital
  • •o History of MI that occurred more than 48 hours but less than 6 weeks prior
  • •to CABG surgery
  • •o Prior peripheral artery surgery or angioplasty
  • •o Moderate renal dysfunction defined as creatinine clearance > 30 ml/min, but
  • •< 60 ml/min
  • •o Presence of at least one asymptomatic carotid artery stenosis (>50%) either
  • •in one or two carotid arteries
  • •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

  • •Planned associated valve surgery or concurrent carotid endarterectomy
  • •Planned aortic dissection repair or aortic root reconstruction
  • •Screening visit occurring less than 4 hours before scheduled CABG surgery
  • •MMSE Score less than 24 at the screening visit
  • •Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture,
  • •or papillary muscle rupture
  • •Uncontrolled diabetes defined as fasting serum blood glucose value equal to or
  • •greater than 24 mmol/L (432 mg/dl) at the time of screening (if fasting serum blood
  • •glucose not obtained at screening, values obtained within 30 days prior to screening
  • •visit may be used)
  • •MI occurring <48 hours prior to planned CABG surgery
  • •Severe renal dysfunction defined as an estimated creatinine clearance value <30
  • •ml/min or nephrotic syndrome at screening (or measured creatinine clearance value
  • •obtained within 30 days prior to screening visit)
  • •History of liver cirrhosis, chronic active hepatitis (known positive serum test within
  • •6 months of enrolment) or severe liver dysfunction, or known liver transaminase =3 times ULN
  • •History of malignancy during the last 5 years except for basal cell carcinoma
  • •Planned surgery for atrial fibrillation
  • •Planned associated transmyocardial revascularization
  • •Planned associated ventricular remodeling
  • •Pregnancy, as determined by a pregnancy test
  • •Any medical or psychiatric condition which in the opinion of the investigator makes
  • •the patient an unsuitable candidate for the study
  • •Significant, ongoing alcohol or drug abuse
  • •Participation in any other investigational drug or device study within 30 days of
  • •randomization

研究者

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