IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction - IOCYTE AMI-3

Faraday Pharmaceuticals, Inc.0 个研究点目标入组 2,300 人开始时间: 2021年11月19日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•1. Age = 18 years
•2. Anterior STEMI, based on: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and
•ECG criteria:
•men > 40 years: = 2 mm of ST elevation in V2 and V3
•men = 40 years: = 2.5 mm of ST elevation in V2 and V3
•women = 1.5 mm of ST elevation in V2 and V3
•3. Planned primary PCI to occur = 6 hours of onset of first symptoms of myocardial ischemia
•4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for 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 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1800

•1. Life expectancy of less than 1 year due to non-cardiac pathology
•2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
•3. Known allergy to iodine
•4. Renal disease requiring dialysis
•5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
•6. Body weight >140 kg (or 309 lbs)
•7. Use of thrombolytic therapy as treatment for the index STEMI event
•8. Use of investigational drugs or devices 30 days prior to randomization
•9. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301

发起方