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

NCT01905475 | Completed Phase 2 DMC

• 1 other identifier: POL6326-POL-006
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 17

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).

Conditions

Large Reperfused ST-Elevation Myocardial Infarction

Keywords

STEMI; AMI; repair

Outcome Measures

Primary Outcomes (1)

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

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

  4 months

Secondary Outcomes (4)

• Additional measures of cardiovascular function

  4 months

• Mobilization of stem and progenitor cells

  2 days

• Pharmacokinetic outcome

  2 days

• Safety of POL6326 by intravenous infusion

  12 months

Study Arms (2)

POL6326

EXPERIMENTAL

POL6326 intravenous infusion

Drug: POL6326

Placebo

PLACEBO COMPARATOR

Placebo intravenous infusion

Drug: Placebo

Interventions

POL6326 DRUG

POL6326

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must be scheduled to undergo coronary angiography for the purposes of primary PCI (percutaneous coronary intervention) culminating in successful stent implantation.
• 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.
• Markedly reduced LVEF at baseline cardiac MRI.
• No previous occurrence of Myocardial Infarction.
• Estimated glomerular filtration rate (eGFR) equal or higher than 40 mL/minute prior to MRI.
• Signed Informed Consent.

You may not qualify if:

• Evidence of multi-vessel coronary artery disease likely to require repeat PCI or coronary artery bypass grafting within 4 months.
• Pulmonary oedema or cardiogenic shock requiring intubation or mechanical support at the time of the planned baseline MRI.
• Fitted with a non-MRI-compatible cardiac pacemaker or implantable cardioverter defibrillator, or expected to require such a device within 4 months after randomisation.
• Terminal illness or malignant disease.
• Advanced hepatic disease.
• Diagnosis of severe obesity which precludes MRI assessments.
• Claustrophobia.
• Acute systemic infection or fever.
• Anemia (where hemoglobin levels are \<10 g/dL), thrombocytopenia (platelet count \<100000/μL) or coagulopathy.
• History of multiple drug allergies or with a known allergy to the drug class of CXCR4 antagonists.
• Pregnancy or females of childbearing potential who are not using double contraception
• 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.
• Patients who have participated in any investigational drug or device trial within 30 days prior to signing informed consent.
• Patients who are unwilling or unable to abide by the study requirements.

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (17)

Medical University of Graz

Graz, 8036, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Charité - Campus Benjamin

Berlin, 12203, Germany

Location

Charité - Campus Virchow

Berlin, 13353, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Semmelweis University

Budapest, 1122, Hungary

Location

Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály

Budapest, 1134, Hungary

Location

DEOEC, Kardiológiai Intézet

Debrecen, 4032, Hungary

Location

Kaposi Mór Teaching Hospital

Kaposvár, 7400, Hungary

Location

Pécs University

Pécs, 7624, Hungary

Location

Zala Megyei Kórház,Kardiológia

Zalaegerszeg, 8900, Hungary

Location

Hospital John Paul II

Krakow, 31-202, Poland

Location

Edinburgh Heart Centre Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

University Hospitals of Leicester NHS Trust Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

balixafortide

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Kai C. Wollert, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

DE (4); AU (2); HU (6); PL (1); GB (4)