NCT00326976已完成2 期
A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Measure the Effect of FX06 (a Fibrin Derived Peptide Bbeta15-42) on Ischemia Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention (PCI): The "F.I.R.E." Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 32
- 主要终点
- Infarct size as measured by cardiac MRI
研究概览
简要总结
The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients who have given informed consent
- •Patients after primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI)
- •Men or women with no child bearing potential
- •Onset of symptoms to balloon time < 6 hours
- •ST-elevation of at least 2 mm in at least 3 leads on 12-lead electrocardiogram (ECG)
- •Primary PCI indicated per standard of care
- •First myocardial infarction (MI)
- •Single index lesion with complete occlusion [thrombolysis in myocardial infarction (TIMI) flow 0/I] of one target vessel.
排除标准
- •History of MI (from patient history, or from ECG)
- •Chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the acute myocardial infarction (AMI)
- •Need for coronary artery bypass graft (CABG)
- •Administration of any thrombolytic agent since onset of AMI symptoms
- •Serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, LM dissection, etc.)
- •Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents
- •Contraindication to cardiovascular magnetic resonance (CMR): claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; frequent extrasystoles (> 12/Min) or atrial fibrillation (AF).
- •Known renal dysfunction defined as serum creatinine > 250 µmol/l
- •Previous CABG
- •History of congestive heart failure (CHF)
- •Body mass index (BMI) > 35
- •Patients who cannot communicate reliably with the investigator
- •Patients who are unlikely to cooperate with the requirements of the study
- •Patients who are unwilling and/or unable to give informed consent
- •Patients at increased risk of death from a pre-existing concurrent illness
- •Patients participating in another clinical study
- •Patients who have used any other investigational drugs within 1 month of first dosing
- •Patients who have participated already in this study
- •Patients who are employees at the investigational site; relatives or spouse of the investigator.
研究组 & 干预措施
1
Experimental
400 mg injected in 2 divided boluses
干预措施: FX06 (Drug)
1
Experimental
400 mg injected in 2 divided boluses
干预措施: Percutaneous coronary intervention (Procedure)
2
Placebo Comparator
Matching placebo
干预措施: FX06 (Drug)
2
Placebo Comparator
Matching placebo
干预措施: Percutaneous coronary intervention (Procedure)
结局指标
主要结局
Infarct size as measured by cardiac MRI
时间窗: 5-7 days post intervention
次要结局
- Myocardial scar mass and left ventricular function(4 months post intervention)
研究者
研究点 (32)
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