Back to resultsCXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) (CATCH-AMI)
Primary Purpose
Large Reperfused ST-Elevation Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
POL6326
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Large Reperfused ST-Elevation Myocardial Infarction focused on measuring STEMI, AMI, repair
Eligibility Criteria
Inclusion Criteria:
- Patients with symptoms suggestive of an acute MI with ST-segment elevation or new left bundle-branch block and a rise or fall in cardiac necrosis markers.
- Patients must be scheduled to undergo coronary angiography for the purposes of primary PCI (percutaneous coronary intervention) culminating in successful stent implantation.
- Age between 18 and 80 years. Male and WOCBP (women of child bearing potential) willing to use highly effective methods of contraception from the time of first dose until 3 months after the last dose of the drug.
- Markedly reduced LVEF at baseline cardiac MRI.
- No previous occurrence of Myocardial Infarction.
- Estimated glomerular filtration rate (eGFR) equal or higher than 40 mL/minute prior to MRI.
- Signed Informed Consent.
Exclusion Criteria:
- Evidence of multi-vessel coronary artery disease likely to require repeat PCI or coronary artery bypass grafting within 4 months.
- Pulmonary oedema or cardiogenic shock requiring intubation or mechanical support at the time of the planned baseline MRI.
- Fitted with a non-MRI-compatible cardiac pacemaker or implantable cardioverter defibrillator, or expected to require such a device within 4 months after randomisation.
- Terminal illness or malignant disease.
- Advanced hepatic disease.
- Diagnosis of severe obesity which precludes MRI assessments.
- Claustrophobia.
- Acute systemic infection or fever.
- Anemia (where hemoglobin levels are <10 g/dL), thrombocytopenia (platelet count <100000/μL) or coagulopathy.
- History of multiple drug allergies or with a known allergy to the drug class of CXCR4 antagonists.
- Pregnancy or females of childbearing potential who are not using double contraception
- Known history of human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection or significant active chronic inflammatory disease that requires immunosuppressive medication or regular systemic corticosteroids.
- Patients who have participated in any investigational drug or device trial within 30 days prior to signing informed consent.
- Patients who are unwilling or unable to abide by the study requirements.
Sites / Locations
- Medical University of Graz
- Medical University of Vienna
- Kerckhoff-Klinik GmbH
- Charité - Campus Benjamin
- Charité - Campus Virchow
- Hannover Medical School
- Semmelweis University
- Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály
- DEOEC, Kardiológiai Intézet
- Kaposi Mór Teaching Hospital
- Pécs University
- Zala Megyei Kórház,Kardiológia
- Hospital John Paul II
- Edinburgh Heart Centre Royal Infirmary
- West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital
- University Hospitals of Leicester NHS Trust Glenfield Hospital
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
POL6326
Placebo
Arm Description
POL6326 intravenous infusion
Placebo intravenous infusion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Mobilization of stem and progenitor cells
Time dependent measurement of stem and progenitor cells during and after infusion of POL6326
Pharmacokinetic outcome
Measurement of plasma concentrations of POL6326 at predose and several time points after infusion.
Safety of POL6326 by intravenous infusion
Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01905475
Brief Title
CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)
Acronym
CATCH-AMI
Official Title
CXCR4 AnTagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI). A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients With Large Reperfused ST Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyphor Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large Reperfused ST-Elevation Myocardial Infarction
Keywords
STEMI, AMI, repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
POL6326
Arm Type
Experimental
Arm Description
POL6326 intravenous infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo intravenous infusion
Intervention Type
Drug
Intervention Name(s)
POL6326
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in LVEF (left ventricular ejection fraction) as determined by MRI
Description
Difference in LVEF from baseline (after STEMI and stent procedure, before infusion of drug or placebo) and after 4 months
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Additional measures of cardiovascular function
Description
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
Title
Mobilization of stem and progenitor cells
Description
Time dependent measurement of stem and progenitor cells during and after infusion of POL6326
Time Frame
2 days
Title
Pharmacokinetic outcome
Description
Measurement of plasma concentrations of POL6326 at predose and several time points after infusion.
Time Frame
2 days
Title
Safety of POL6326 by intravenous infusion
Description
Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptoms suggestive of an acute MI with ST-segment elevation or new left bundle-branch block and a rise or fall in cardiac necrosis markers.
Patients must be scheduled to undergo coronary angiography for the purposes of primary PCI (percutaneous coronary intervention) culminating in successful stent implantation.
Age between 18 and 80 years. Male and WOCBP (women of child bearing potential) willing to use highly effective methods of contraception from the time of first dose until 3 months after the last dose of the drug.
Markedly reduced LVEF at baseline cardiac MRI.
No previous occurrence of Myocardial Infarction.
Estimated glomerular filtration rate (eGFR) equal or higher than 40 mL/minute prior to MRI.
Signed Informed Consent.
Exclusion Criteria:
Evidence of multi-vessel coronary artery disease likely to require repeat PCI or coronary artery bypass grafting within 4 months.
Pulmonary oedema or cardiogenic shock requiring intubation or mechanical support at the time of the planned baseline MRI.
Fitted with a non-MRI-compatible cardiac pacemaker or implantable cardioverter defibrillator, or expected to require such a device within 4 months after randomisation.
Terminal illness or malignant disease.
Advanced hepatic disease.
Diagnosis of severe obesity which precludes MRI assessments.
Claustrophobia.
Acute systemic infection or fever.
Anemia (where hemoglobin levels are <10 g/dL), thrombocytopenia (platelet count <100000/μL) or coagulopathy.
History of multiple drug allergies or with a known allergy to the drug class of CXCR4 antagonists.
Pregnancy or females of childbearing potential who are not using double contraception
Known history of human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection or significant active chronic inflammatory disease that requires immunosuppressive medication or regular systemic corticosteroids.
Patients who have participated in any investigational drug or device trial within 30 days prior to signing informed consent.
Patients who are unwilling or unable to abide by the study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai C. Wollert, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité - Campus Benjamin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charité - Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
DEOEC, Kardiológiai Intézet
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Kaposi Mór Teaching Hospital
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Pécs University
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Zala Megyei Kórház,Kardiológia
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Hospital John Paul II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Edinburgh Heart Centre Royal Infirmary
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
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CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)
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