The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a stem cell mobilizing agent, on cardiac function and infarct size and on safety and tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).
After acute myocardial infarction and successful stent implantation patients will undergo a baseline MRI (magnetic resonance imaging) for eligibility for the study. Patients will receive POL6326 or placebo in the first week after STEMI. The primary and secondary endpoints will also be determined in a follow-up visit after 12 months. An interim analysis will be performed after 50% of the patients have completed the 4 months MRI assessment and may result in an adjustment of study size. A number of pre-specified subgroups will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Medical University of Graz
Graz, Austria
Medical University of Vienna
Vienna, Austria
Change in LVEF (left ventricular ejection fraction) as determined by MRI
Difference in LVEF from baseline (after STEMI and stent procedure, before infusion of drug or placebo) and after 4 months
Time frame: 4 months
Additional measures of cardiovascular function
Using MRI the following parameters will also be determined: infarct size, LV volumes, regional LV function. Plasma BNP (brain natriuretic peptide) will also be determined.
Time frame: 4 months
Mobilization of stem and progenitor cells
Time dependent measurement of stem and progenitor cells during and after infusion of POL6326
Time frame: 2 days
Pharmacokinetic outcome
Measurement of plasma concentrations of POL6326 at predose and several time points after infusion.
Time frame: 2 days
Safety of POL6326 by intravenous infusion
Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)
Time frame: 12 months
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