EUCTR2009-009657-19-DE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, multi-center study of IK-1001 to evaluate safety, population pharmacokinetics and proof-of-concept efficacy for reduction of ischemia-reperfusion mediated cardiac injury in subjects undergoing coronary artery bypass graft (CABG) surgery.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ikaria, Inc.
- 入组人数
- 668
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
- •1. Subjects must be 18 to 85 years of age
- •2. Subject is scheduled to undergo CABG surgery with cardiopulmonary
- •3. Subjects at an increased risk for I/R mediated tissue damage: defined as
- •subjects with = 30% but = 50% ejection fraction (as measured by:
- •echocardiography within 14 days of study enrollment) or who fulfill at
- •least two of the following criteria:
- •Current or recent smoker (within last 6 months prior to screening)
- •. Diabetes mellitus (a history of diabetes, regardless of duration of disease
- •or need for antidiabetic agents)
- •History of non-disabling stroke, transient ischemic attack (TIA), or carotid
- •endarterectomy
- •Re-CABG surgery (history of [H/O] previous CABG surgery by any
- •approach, on or off pump)
- •Peripheral artery surgery or angioplasty
- •Recent MI (= 48 hours and = 6 weeks before enrollment, non-STEMI and STEMI
- •infarcts as documented in the medical records of the subject)
- •History of congestive heart failure (CHF) (NYHAssociation CHF Class III or IV)
- •Renal dysfunction (creatinine clearance = 30mL/min, but < 60mL/min) calculated
- •using Cockroft and Gault formula:
- •Asymptomatic stenosis (= 50%) in = 1 carotid artery
- •Age > 65 years
- •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
- •1. Known sulfite allergy or sulphur drug allergy.
- •2. Myocardial infarction occurring < 48 hours prior to surgery.
- •3. Current cardiogenic shock, acute left ventricular rupture, ventricular septal
- •rupture, or papillary muscle rupture
- •4. Subject has an ejection fraction = 30% (as measured by echocardiography within
- •14 days of study enrollment)
- •5. History of prior disabling stroke
- •6. Severe renal dysfunction defined as a creatinine clearance of < 30mL/min
- •7. Clinically relevant liver disease (serum transaminases = ULN x 3)
- •8. Uncontrolled diabetes mellitus (HbA1c > 9.0%)
- •9. Planned concomitant valve or other surgery
- •10. All females of child bearing potential as determined by medical history and
- •Principal Investigator evaluation
- •11. Ongoing alcohol -or drug abuse
- •12. Any underlying medical or psychiatric condition that, in the opinion of the
- •investigator, makes the subject an unsuitable candidate for the study
- •13. Subject has participated in another investigational drug or device study within
- •30 days prior to enrollment to the study.
研究者
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