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

Sponsor
Polyphor Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01905475
Collaborator
(none)
120
Enrollment
17
Locations
2
Arms
35
Duration (Months)
7.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: POL6326

POL6326 intravenous infusion

Drug: POL6326
Placebo Comparator: Placebo

Placebo intravenous infusion

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Change in LVEF (left ventricular ejection fraction) as determined by MRI [4 months]

    Difference in LVEF from baseline (after STEMI and stent procedure, before infusion of drug or placebo) and after 4 months

Secondary Outcome Measures

  1. Additional measures of cardiovascular function [4 months]

    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.

  2. Mobilization of stem and progenitor cells [2 days]

    Time dependent measurement of stem and progenitor cells during and after infusion of POL6326

  3. Pharmacokinetic outcome [2 days]

    Measurement of plasma concentrations of POL6326 at predose and several time points after infusion.

  4. Safety of POL6326 by intravenous infusion [12 months]

    Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
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
5 Charité - Campus Virchow Berlin Germany 13353
6 Hannover Medical School Hannover Germany 30625
7 Semmelweis University Budapest Hungary 1122
8 Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály Budapest Hungary 1134
9 DEOEC, Kardiológiai Intézet Debrecen Hungary 4032
10 Kaposi Mór Teaching Hospital Kaposvár Hungary 7400
11 Pécs University Pecs Hungary 7624
12 Zala Megyei Kórház,Kardiológia Zalaegerszeg Hungary 8900
13 Hospital John Paul II Krakow Poland 31-202
14 Edinburgh Heart Centre Royal Infirmary Edinburgh United Kingdom EH16 4SA
15 West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital Glasgow United Kingdom G81 4DY
16 University Hospitals of Leicester NHS Trust Glenfield Hospital Leicester United Kingdom LE3 9QP
17 King's College Hospital London United Kingdom SE5 9RS

Sponsors and Collaborators

  • Polyphor Ltd.

Investigators

  • Principal Investigator: Kai C. Wollert, MD, Hannover Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Polyphor Ltd.
ClinicalTrials.gov Identifier:
NCT01905475
Other Study ID Numbers:
  • POL6326-POL-006
First Posted:
Jul 23, 2013
Last Update Posted:
Jun 10, 2016
Last Verified:
Jun 1, 2016
Keywords provided by Polyphor Ltd.
STEMI
AMI
repair
Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction

Study Results

No Results Posted as of Jun 10, 2016