Status:
COMPLETED
CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)
Lead Sponsor:
Polyphor Ltd.
Conditions:
Large Reperfused ST-Elevation Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01905475
Start Date
July 1 2013
End Date
June 1 2016
Last Update
June 10 2016
Active Locations (17)
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1
Medical University of Graz
Graz, Austria, 8036
2
Medical University of Vienna
Vienna, Austria, 1090
3
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
4
Charité - Campus Benjamin
Berlin, Germany, 12203