A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction - REAL-TIMI 63B

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 个研究点目标入组 593 人开始时间: 2018年3月27日最近更新: 2023年9月4日

研究概览

暂无简介。

•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 pPCI
•4. Ischemic symptoms for = 6 hours
•5. Capable of completing study visits
•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 345
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 195

•1. Pre-randomization cardiogenic shock or cardiopulmonary resuscitation
•2. Fibrinolytic administration for index event
•3. Known prior MI or prior coronary artery bypass graft (CABG) surgery
•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 Cr/Cl<30mL/min (Cockcroft Gault equation)
•9. Pregnant women and/or breastfeeding women
•10. Current or previous participation within last 30 days in a study using an investigational therapy or device.

发起方

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC