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

Fibrex Medical Research & Development GmbH0 个研究点目标入组 120 人开始时间: 2006年6月28日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Patients who have given informed consent.
•2. Patients at risk of ischemia/reperfusion injury after primary PCI for acute STEMI;
•3. Men or women with no child-bearing potential (e.g., post-menopause, surgically sterile);
•4. 18 – 80 years old;
•5. Onset of symptoms to balloon time < 6 hrs;
•6. ST elevation of at least 2 mm in at least 3 leads on 12-lead ECG;
•7. Primary PCI indicated per standard of care;
•8. First MI;
•9. Single index lesion with complete occlusion (TIMI flow 0/I) of one target vessel. The presence of 2 or 3 vessel disease is not an exclusion criterion so far as there is
•no other occlusion and as long as no intervention is considered, neither ad hoc nor as a staged procedure
•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

•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.Serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, LM dissection, etc.);
•6.Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents;
•7.Contra indication to CMR: claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; Frequent extrasystoles (< 12/Min) or AF;
•8.Known renal dysfunction defined as serum creatinine > 250 µmol/l;
•9.Previous CABG;
•10.History of CHF;
•11.BMI > 35;
•12.Patients who cannot communicate reliably with the investigator;
•13.Patients who are unlikely to cooperate with the requirements of the study;
•14.Patients who are unwilling and/or unable to give informed consent;
•15.Patients at increased risk of death from a pre-existing concurrent illness;
•16.Patients participating in another clinical study;
•17.Patients who have used any other investigational drugs within 1 month of first dosing;
•18.Patients who have participated already in this study;
•19.Patients who are employees at the investigational site, relatives or spouse of the investigator.

发起方