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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POL6326 | Experimental | POL6326 intravenous infusion |
|
| Placebo | Placebo Comparator | Placebo intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL6326 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| Mobilization of stem and progenitor cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai C. Wollert, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria | |||
| Medical University of Vienna |
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|
Time dependent measurement of stem and progenitor cells during and after infusion of POL6326 |
| 2 days |
| Pharmacokinetic outcome | Measurement of plasma concentrations of POL6326 at predose and several time points after infusion. | 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) | 12 months |
| Vienna |
| 1090 |
| Austria |
| Kerckhoff-Klinik GmbH | Bad Nauheim | 61231 | Germany |
| Charité - Campus Benjamin | Berlin | 12203 | Germany |
| Charité - Campus Virchow | Berlin | 13353 | Germany |
| Hannover Medical School | Hanover | 30625 | Germany |
| Semmelweis University | Budapest | 1122 | Hungary |
| Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály | Budapest | 1134 | Hungary |
| DEOEC, Kardiológiai Intézet | Debrecen | 4032 | Hungary |
| Kaposi Mór Teaching Hospital | Kaposvár | 7400 | Hungary |
| Pécs University | Pécs | 7624 | Hungary |
| Zala Megyei Kórház,Kardiológia | Zalaegerszeg | 8900 | Hungary |
| Hospital John Paul II | Krakow | 31-202 | Poland |
| Edinburgh Heart Centre Royal Infirmary | Edinburgh | EH16 4SA | United Kingdom |
| West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital | Glasgow | G81 4DY | United Kingdom |
| University Hospitals of Leicester NHS Trust Glenfield Hospital | Leicester | LE3 9QP | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C000624271 | balixafortide |
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