A Phase 2A, Randomized, Double-Blind, Placebo- Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction

Faraday Pharmaceuticals, Inc.0 个研究点目标入组 160 人开始时间: 2017年8月3日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. 18-80 year old male subjects
•2. 18 to 80 year old female subjects who are not of childbearing potential
•3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the Jpoint in two contiguous leads with the cut-off points: =0.2 millivolt (mV) in men or =0.15 mV in women in leads V2-V3 and/or =0.1 mV in other leads), within 12 hours of symptom onset
•4. Assent/Informed consent to study participation
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. Previous myocardial infarction
•2. Left bundle branch block (LBBB)
•3. Previous coronary artery bypass graft surgery (CABG)
•4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
•5. Known contraindication to CMR (e.g. pacemaker)
•6. Patients with known thyroid disease, or known allergy to iodide
•7. Subjects with past or current renal impairment requiring dialysis
•8. Pregnant or females of childbearing potential
•9. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
•10. Use of investigational drugs or devices within 30 days prior to enrollment into the study
•11. Life expectancy of less than 1 year due to non-cardiac pathology
•12. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator
•or any sub-Investigator would preclude safe completion of the study

发起方