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-DK
• Lead Sponsor: Fibrex Medical Research & Development GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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.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.

Study & Design

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