A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 23
- 主要终点
- Arrhythmias of Interest, 48 Hours (Overall)
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.
详细描述
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA).
A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury".
FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug.
Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 year old male subjects
- •18 to 80 year old female subjects who are not of child-bearing potential.
- •Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the J-point 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.
- •Written informed consent prior to study participation (either by the subject or a legally authorized representative of the subject)
排除标准
- •Previous myocardial infarction
- •Left bundle branch block (LBBB)
- •Previous coronary artery bypass graft surgery (CABG)
- •Major hemodynamic instability or uncontrolled ventricular arrhythmias
- •Known contraindication to CMR
- •Patients with known thyroid disease
- •Subjects with past or current renal impairment requiring dialysis
- •Pregnant or females of child bearing potential
- •Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
- •Use of investigational drugs or devices within 30 days prior to enrollment into the study.
- •Life expectancy of less than 1 year due to non-cardiac pathology
- •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
研究组 & 干预措施
Placebo
Anticipated n=20
干预措施: Placebo (Other)
FDY-5301 Low Dose
Anticipated n=20
干预措施: FDY-5301 (Drug)
FDY-5301 Intermediate Dose
Anticipated n=20
干预措施: FDY-5301 (Drug)
FDY-5301 High Dose
Anticipated n=20
干预措施: FDY-5301 (Drug)
结局指标
主要结局
Arrhythmias of Interest, 48 Hours (Overall)
时间窗: First 48 hours post-treatment
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
时间窗: 48 hours post-treatment
Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
时间窗: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Arrhythmias of Interest, 14 Days (Overall)
时间窗: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
次要结局
- Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)(72 hours post-treatment)
- Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)(3 months post-treatment)
- Left Ventricular End Systolic Volume Index, 3 Months (Overall)(3 months post-treatment)
- Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)(72 hours post-treatment)
- Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)(3 months post-treatment)
- Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)(3 months post-treatment)
- Serum Troponin Concentrations, 48 Hours (Overall)(48 hours post-treatment)
- Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)(48 hours post-treatment)
- ST-segment Resolution(4 hours post-dose)
- Left Ventricular End Systolic Volume Index, 72 Hours (Overall)(72 hours post-treatment)
- Infarct Size Relative to Ventricular Volume, 3 Months (Overall)(3 months post-treatment)
- Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)(72 hours post-treatment)
- Left Ventricular Ejection Fraction, 72 Hours (Overall)(72 hours post-treatment)
- Left Ventricular Ejection Fraction, 3 Months (Overall)(3 months post-treatment)
- Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)(72 hours post-treatment)