Clinical trial NCT01905475: CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Large Reperfused ST-Elevation Myocardial Infarction
Keywords: STEMI
AMI
repair
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients must be scheduled to undergo coronary angiography for the purposes of primary PCI (percutaneous coronary intervention) culminating in successful stent implantation.
3. 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.
4. Markedly reduced LVEF at baseline cardiac MRI.
5. No previous occurrence of Myocardial Infarction.
6. Estimated glomerular filtration rate (eGFR) equal or higher than 40 mL/minute prior to MRI.
7. Signed Informed Consent.

Exclusion Criteria:

1. Evidence of multi-vessel coronary artery disease likely to require repeat PCI or coronary artery bypass grafting within 4 months.
2. Pulmonary oedema or cardiogenic shock requiring intubation or mechanical support at the time of the planned baseline MRI.
3. Fitted with a non-MRI-compatible cardiac pacemaker or implantable cardioverter defibrillator, or expected to require such a device within 4 months after randomisation.
4. Terminal illness or malignant disease.
5. Advanced hepatic disease.
6. Diagnosis of severe obesity which precludes MRI assessments.
7. Claustrophobia.
8. Acute systemic infection or fever.
9. Anemia (where hemoglobin levels are \<10 g/dL), thrombocytopenia (platelet count \<100000/μL) or coagulopathy.
10. History of multiple drug allergies or with a known allergy to the drug class of CXCR4 antagonists.
11. Pregnancy or females of childbearing potential who are not using double contraception
12. 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.
13. Patients who have participated in any investigational drug or device trial within 30 days prior to signing informed consent.
14. Patients who are unwilling or unable to abide by the study requirements.

Primary outcomes:
measure: Change in LVEF (left ventricular ejection fraction) as determined by MRI
timeFrame: 4 months
Secondary outcomes:
measure: Additional measures of cardiovascular function
timeFrame: 4 months
measure: Mobilization of stem and progenitor cells
timeFrame: 2 days
measure: Pharmacokinetic outcome
timeFrame: 2 days
measure: Safety of POL6326 by intravenous infusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Berlin
country: Germany
facility: Charité - Campus Benjamin
city: Berlin
country: Germany
facility: Charité - Campus Virchow
city: Hannover
country: Germany
facility: Hannover Medical School
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály
city: Debrecen
country: Hungary
facility: DEOEC, Kardiológiai Intézet
city: Kaposvár
country: Hungary
facility: Kaposi Mór Teaching Hospital
city: Pecs
country: Hungary
facility: Pécs University
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház,Kardiológia
city: Krakow
country: Poland
facility: Hospital John Paul II
city: Edinburgh
country: United Kingdom
facility: Edinburgh Heart Centre Royal Infirmary
city: Glasgow
country: United Kingdom
facility: West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust Glenfield Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Hannover Medical School
name: Kai C. Wollert, MD
role: PRINCIPAL_INVESTIGATOR
References: