Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatment bl-1040
Phase phase 1/phase 2
Sponsor BioLineRx, Ltd.
Collaborator Sheba Medical Center
Start date March 2008
End date January 2010
Trial size 30 participants
Trial identifier NCT00557531, 1040.01

Summary

This is a Phase I, multi-center, open label study designed to assess the safety and feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial tissue.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bl-1040
2 mL of BL-1040

Primary Outcomes

Measure
Occurrence of all AEs including but not limited to All MIs CV hospitalization Serious ventricular arrhythmias sustained: Symptomatic heart failure Renal failure Stroke Death
time frame: 6 months

Secondary Outcomes

Measure
Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria

  • Signed informed consent
  • 18 to 75 years of age, inclusive
  • Male or female
  • Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal
  • Acute MI defined as:
    • Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
    • Ischemic symptoms;
    • Development of pathologic Qwaves on the ECG;
    • ECG changes indicative of ischemia (ST segment elevation or depression)
    • First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads])
    • Regional wall motion score index (at least 4 out of 16 akinetic segments)
  • One or more of the following:
    • LVEF >20% and <45% measured and calculated by 2-dimensional measurement
    • Biomarkers: peak CK > 2000 IU
    • Infarct size > 25% as measured by MRI
    • Successful revascularization with PCI with 1 stent only, within 7 days of the index MI
    • At time of application of study device, patient must have patent infarct related artery (IRA) and TIMI flow grade = 3

Exclusion Criteria

  • History of CHF, Class I to Class IV, as per NYHA criteria
  • History of prior LV dysfunction
  • At time of application of study device - Killip III-IV (pulmonary edema, cardiogenic shock - hypotension systolic < 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR > 100 bpm
  • Prior CABG
  • Prior MI
  • History of stroke
  • Significant valvular disease (moderate or severe)
  • Patient is a candidate for CABG or PCI on non-IRA
  • Patient is being considered for CRT within the next 30 days
  • Renal insufficiency (eGFR < 60)
  • Chronic liver disease (> 3 times upper limit of normal)
  • Life expectancy < 12 months
  • Current participant in another clinical trial, or participation in another trial within the last 6 months
  • Any contraindication to coronary angiography, MRI or PCI procedures
  • Patient taking anti-coagulation medication prior to MI
  • Pregnant or lactating women; pregnancy confirmed by urine pregnancy test

Additional Information

Official title Safety and Feasibility of the Injectable BL-1040 Implant
Principal investigator Paul Vermeersch, MD
Description ENDPOINTS Preliminary safety endpoints Occurrence of all adverse events including but not limited to All MIs Cardiovascular hospitalization Serious ventricular arrhythmias sustained: VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse]) VF symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block Symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) Renal failure Stroke Death Secondary safety endpoints Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by BioLineRx, Ltd..