NL-OMON48930已完成2 期
A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction - MEDI6012
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Men and women without child-bearing potential aged 30-80 years of age who
- •are capable and willing to provide informed consent.
- •2. Acute STEMI diagnosed by ST elevation (* 0.1 mV) in 2 contiguous leads
- •3. Planned for primary PCI
- •4. Ischemic symptoms for * 6 hours
- •5. Capable of completing study visit
排除标准
- •1. Pre-randomization cardiogenic shock or cardiopulmonary resuscitation
- •2. Fibrinolytic administration for index event
- •3. Known prior MI or prior coronary artery bypass grafting
- •4. Known pre-existing cardiomyopathy
- •5. History of anaphylaxis
- •6. Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo
- •cardiomyopathy)
- •7. Other condition or severe illness that the investigator feels would limit
- •the prognosis of the patient (eg, malignancy with life-expectancy < 3 months)
- •or would make the patient otherwise unsuitable for enrollment (eg, pose a
- •hazard or undue burden to the patient [known chronic renal or hepatic
- •impairment, recent (< 30 days), cerebrovascular accident or transient ischemic
- •attack] unable to complete study visits)
- •8. Known contraindication to MR imaging (eg, metallic implant, claustrophobia,
- •implantable cardioverter-defibrillator (ICD), pacemaker, known CrCl < 30 mL/min
- •(Cockcroft Gault equation)
- •9. Pregnant women and/or breastfeeding women.
- •10. Current or previous participation within the last 30 days in a study using
- •an investigational therapy or device.
研究者
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