CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) (CATCH-AMI)

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

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).

Study Overview

• Status: Completed
• Conditions: Large Reperfused ST-Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Placebo; Drug: POL6326

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz
  • Vienna, Austria, 1090
    • Medical University of Vienna
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik GmbH
  • Berlin, Germany, 13353
    • Charité - Campus Virchow
  • Berlin, Germany, 12203
    • Charité - Campus Benjamin
  • Hannover, Germany, 30625
    • Hannover Medical School
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University
  • Budapest, Hungary, 1134
    • Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály
  • Debrecen, Hungary, 4032
    • DEOEC, Kardiológiai Intézet
  • Kaposvár, Hungary, 7400
    • Kaposi Mor Teaching Hospital
  • Pecs, Hungary, 7624
    • Pécs University
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Kórház,Kardiológia
• Poland
  • Krakow, Poland, 31-202
    • Hospital John Paul II
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Edinburgh Heart Centre Royal Infirmary
  • Glasgow, United Kingdom, G81 4DY
    • West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital
  • Leicester, United Kingdom, LE3 9QP
    • University Hospitals of Leicester NHS Trust Glenfield Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo intravenous infusion	Drug: Placebo
Experimental: POL6326; POL6326 intravenous infusion	Drug: POL6326

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Polyphor Ltd.
• Investigators: Principal Investigator: Kai C. Wollert, MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: STEMI; AMI; repair
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: POL6326-POL-006