Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

F

Fibrex Medical Research & Development GmbH

Status and phase

Completed
Phase 2

Conditions

Myocardial Ischemia
Myocardial Infarction
Coronary Disease

Treatments

Drug: FX06
Procedure: Percutaneous coronary intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT00326976
FX06AQ-II-01

Details and patient eligibility

About

The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

Enrollment

234 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

234 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
400 mg injected in 2 divided boluses
Treatment:
Procedure: Percutaneous coronary intervention
Drug: FX06
2
Placebo Comparator group
Description:
Matching placebo
Treatment:
Procedure: Percutaneous coronary intervention
Drug: FX06

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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