NL-OMON54138招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 260
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. 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
- •Electrocardiogram (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 persistent symptoms that
- •caused the patient to pursue medical care for myocardial infarction.
- •4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
- •approved consent obtained for study participation
排除标准
- •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 or the excipient of the investigational product
- •(sodium chloride)
- •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 within 30 days or 5 half-lives whichever is
- •longer, prior to randomization or the use of investigational devices within 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
研究者
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