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

• Conditions: Patients with acute myocardial infarction (AMI) indicated for Percutaneous Coronary Intervention (PCI).; MedDRA version: 8.0Level: LLTClassification code 10000891

• Registration Number: EUCTR2006-000619-51-DE
• Lead Sponsor: Fibrex Medical Research & Development GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified