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Trial · Interventional

CompletedPhase 2Registry data

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

Short name CATCH-AMI

NCTNCT01905475 (opens ClinicalTrials.gov in a new tab)Other idPOL6326-POL-006
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
120 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Randomized · Quadruple masking
Countries
5 countries

Austria, Germany, Hungary, Poland, United Kingdom

Start
Jul 2013
Primary completion
Oct 2015
Completion
Jun 2016
First posted
23 Jul 2013 (estimated)
Last update posted
10 Jun 2016 (estimated)
Conditions
Large Reperfused ST-Elevation Myocardial Infarction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 2

    CATCH-AMI

    NCT01905475

    Jul 2013 to Jun 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • POL6326Drug
  • PlaceboDrug

Arms2

  • Experimental

    POL6326

    POL6326 intravenous infusion

  • Placebo comparator

    Placebo

    Placebo intravenous infusion

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in LVEF (left ventricular ejection fraction) as determined by MRI

    Time frame · 4 months

    Registry description

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

Secondary outcomes(4)

  1. Additional measures of cardiovascular function

    Time frame · 4 months

    Registry description

    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

    Time frame · 2 days

    Registry description

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

  3. Pharmacokinetic outcome

    Time frame · 2 days

    Registry description

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

  4. Safety of POL6326 by intravenous infusion

    Time frame · 12 months

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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