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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Polyphor Ltd.
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.
ClinicalTrials.gov Identifier:
NCT01905475
First received: July 18, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Large Reperfused ST-Elevation Myocardial Infarction
Drug: POL6326
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Polyphor Ltd.:

Primary Outcome Measures:
  • Change in LVEF (left ventricular ejection fraction) as determined by MRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 Frame: 2 days ] [ Designated as safety issue: No ]
    Time dependent measurement of stem and progenitor cells during and after infusion of POL6326

  • Pharmacokinetic outcome [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Measurement of plasma concentrations of POL6326 at predose and several time points after infusion.

  • Safety of POL6326 by intravenous infusion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)


Estimated Enrollment: 140
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POL6326
POL6326 intravenous infusion
Drug: POL6326
Placebo Comparator: Placebo
Placebo intravenous infusion
Drug: Placebo

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905475

Contacts
Contact: Kai C. Wollert, MD +49 511 532 4055 wollert.kai@mh-hanover.de
Contact: Klaus Dembowsky, MD +41 61 567 1600 klaus.dembowsky@polyphor.com

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
University Hospital Internal Medicine III Not yet recruiting
Innsbruck, Austria, 6020
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Germany
Kerckhoff-Klinik GmbH Recruiting
Bad Nauheim, Germany, 61231
Charité - Campus Virchow Recruiting
Berlin, Germany, 13353
Charité - Campus Benjamin Recruiting
Berlin, Germany, 12203
Hannover Medical School Recruiting
Hannover, Germany, 30625
Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1122
Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály Recruiting
Budapest, Hungary, 1134
DEOEC, Kardiológiai Intézet Not yet recruiting
Debrecen, Hungary, 4032
Kaposi Mór Teaching Hospital Recruiting
Kaposvár, Hungary, 7400
Pécs University Recruiting
Pecs, Hungary, 7624
Zala Megyei Kórház,Kardiológia Recruiting
Zalaegerszeg, Hungary, 8900
Norway
Oslo Universitetssykehus HF Not yet recruiting
Oslo, Norway, 0450
Poland
Independent Public Clinical Hospital Nr 7 of the Silesian University of Medicine Recruiting
Katowice, Poland, 40-635
Hospital John Paul II Recruiting
Krakow, Poland, 31-202
United Kingdom
Edinburgh Heart Centre Royal Infirmary Recruiting
Edinburgh, United Kingdom, EH16 4SA
West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G81 4DY
University Hospitals of Leicester NHS Trust Glenfield Hospital Recruiting
Leicester, United Kingdom, LE3 9QP
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Polyphor Ltd.
  More Information

No publications provided

Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT01905475     History of Changes
Other Study ID Numbers: POL6326-POL-006
Study First Received: July 18, 2013
Last Updated: May 9, 2014
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Medicines Agency (NoMA)

Keywords provided by Polyphor Ltd.:
STEMI
AMI
repair

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014