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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Polyphor Ltd.
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.
ClinicalTrials.gov Identifier:
NCT01905475
First received: July 18, 2013
Last updated: August 4, 2014
Last verified: August 2014

July 18, 2013
August 4, 2014
July 2013
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01905475 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Large Reperfused ST-Elevation Myocardial Infarction
  • Drug: POL6326
  • Drug: Placebo
  • Experimental: POL6326
    POL6326 intravenous infusion
    Intervention: Drug: POL6326
  • Placebo Comparator: Placebo
    Placebo intravenous infusion
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Kai C. Wollert, MD +49 511 532 4055 wollert.kai@mh-hannover.de
Contact: Klaus Dembowsky, MD +41 61 567 1600 klaus.dembowsky@polyphor.com
Austria,   Germany,   Hungary,   Norway,   Poland,   United Kingdom
 
NCT01905475
POL6326-POL-006
Yes
Polyphor Ltd.
Polyphor Ltd.
Not Provided
Not Provided
Polyphor Ltd.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP