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

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ClinicalTrials.gov Identifier: NCT01905475
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.

Study Description
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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
Large Reperfused ST-Elevation Myocardial Infarction Drug: POL6326 Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
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 : July 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: POL6326
POL6326 intravenous infusion
 Drug: POL6326
Placebo Comparator: Placebo
Placebo intravenous infusion
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in LVEF (left ventricular ejection fraction) as determined by MRI [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 days ]
    Time dependent measurement of stem and progenitor cells during and after infusion of POL6326

  3. Pharmacokinetic outcome [ Time Frame: 2 days ]
    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 ]
    Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905475


Locations
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Sponsors and Collaborators
Polyphor Ltd.
Investigators
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Principal Investigator: Kai C. Wollert, MD Hannover Medical School
More Information
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Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT01905475    
Other Study ID Numbers: POL6326-POL-006
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Keywords provided by Polyphor Ltd.:
STEMI
AMI
repair
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases