EUCTR2006-000619-51-LT进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Measure the Effect of FX06 (a fibrin derived peptide Bß15-42) on Ischemia-Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention (PCI): The F.I.R.E.” Study - The F.I.R.E. Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients who have given informed consent.
- •2. Men or women with no child-bearing potential (e.g. post-menopause with amenorrhea > 2 years, surgically sterile. In case of doubt, a pregnancy test must be performed);
- •3. >/= 18 years old;
- •4. Onset of symptoms to balloon time < 6 hrs;
- •5. ST elevation of at least 2 mm in at least 3 leads on 12-lead ECG;
- •6. Primary PCI indicated per standard of care;
- •7. First MI;
- •8. Single index lesion with complete occlusion (TIMI flow 0/I) of one target vessel.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of MI (from patient history, or from ECG);
- •2.Chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the AMI;
- •3.Need for CABG;
- •4.Administration of any thrombolytic agent since onset of AMI symptoms;
- •5.Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents;
- •6.Contra indication to CMR: claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; Frequent extrasystoles (< 12/Min) or AF;
- •7.Known moderate to severe renal dysfunction defined as glomerular filtration rate (GFR) < 50 ml/min/1.73 m2;
- •8.Previous CABG;
- •9.History of CHF (NYHA-Grade >/= II);
- •10.BMI > 35;
- •11.Patients who cannot communicate reliably with the investigator;
- •12.Patients who are unlikely to cooperate with the requirements of the study;
- •13.Patients who are unwilling and/or unable to give informed consent;
- •14.Patients at increased risk of death from a pre-existing concurrent illness;
- •15.Patients participating in another clinical study;
- •16.Patients who have used any other investigational drugs within 1 month of first dosing;
- •17.Patients who have participated already in this study;
- •18.Patients who are employees at the investigational site, relatives or spouse of the investigator;
- •19. Patients with a known history of clinically relevant abnormal laboratory values for electrolytes, liver function and hematology, e.g.,
- •·AST, ALT, alkaline phosphatase, g-GT > 2.5 x ULN
- •·Total bilirubin, amylase: > 1.5 x ULN
- •·Potassium, calcium: outside normal range
- •·Hemoglobin < 10.0 g/dl
- •20. History of hemorrhagic diathesis or abnormal platelet or clotting function, e.g.,
- •·platelets < 150,000/mm3
- •·INR and partial thromboplastin time (PTT) > 1.5 x ULN
- •21. Patients known to suffer from atherosclerotic diseases (especially cerebrovascular), e.g.,TIA or or CVA (thrombo-embolic or hemorrhagic stroke) in the last 3 months.
研究者
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