Large Reperfused ST-Elevation Myocardial InfarctionPhase 2CATCH-AMINCT01905475
CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)
A Phase 2 study testing POL6326 in people with Large Reperfused ST-Elevation Myocardial Infarction, run by Polyphor Ltd. at 17 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Large Reperfused ST-Elevation Myocardial Infarction
- What is being tested?
- POL6326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Jul 2013to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Hungary6 sites
Semmelweis University
Budapest, 1122
Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály
Budapest, 1134
DEOEC, Kardiológiai Intézet
Debrecen, 4032
Kaposi Mór Teaching Hospital
Kaposvár, 7400
Pécs University
Pécs, 7624
Zala Megyei Kórház,Kardiológia
Zalaegerszeg, 8900
Germany4 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Charité - Campus Benjamin
Berlin, 12203
Charité - Campus Virchow
Berlin, 13353
Hannover Medical School
Hanover, 30625
United Kingdom4 sites
Edinburgh Heart Centre Royal Infirmary
Edinburgh, EH16 4SA
West of Scotland Regional Heart & Lung Center, Golden Jubilee National Hospital
Glasgow, G81 4DY
University Hospitals of Leicester NHS Trust Glenfield Hospital
Leicester, LE3 9QP
King's College Hospital
London, SE5 9RS
Austria2 sites
Medical University of Graz
Graz, 8036
Medical University of Vienna
Vienna, 1090
About this study
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
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).
Read the 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.
- Being tested
- POL6326, Placebo
- Keywords
- STEMI, AMI, repair
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL6326Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| POL6326 | Experimental | POL6326 intravenous infusion Receives: Drug: POL6326 |
| Placebo | Placebo comparator | Placebo intravenous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (4)
Additional measures of cardiovascular function
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.
Measured: 4 months
Mobilization of stem and progenitor cells
Time dependent measurement of stem and progenitor cells during and after infusion of POL6326
Measured: 2 days
Pharmacokinetic outcome
Measurement of plasma concentrations of POL6326 at predose and several time points after infusion.
Measured: 2 days
Safety of POL6326 by intravenous infusion
Safety as measured by incidence, type and severity of adverse events (Major Adverse Cardiovascular Events (MACE), Arrhythmia)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Reperfused ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai C. Wollert, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905475
- Sponsor's protocol ID
- POL6326-POL-006
- Acronym
- CATCH-AMI
- Status last verified
- Jun 2016
- First submitted
- 18 Jul 2013
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01905475
- Acronym / sponsor ID
- CATCH-AMI / POL6326-POL-006
- Keywords
- STEMI, AMI, repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POL6326 | Experimental | Drug: POL6326POL6326 intravenous infusion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo intravenous infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POL6326 | Drug | POL6326 |
| Placebo | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Additional measures of cardiovascular function
Time frame: 4 months
Mobilization of stem and progenitor cells
Time frame: 2 days
Pharmacokinetic outcome
Time frame: 2 days
Safety of POL6326 by intravenous infusion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai C. Wollert, MD principal investigator
Hannover Medical School
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POL6326 in people with Large Reperfused ST-Elevation Myocardial Infarction, run by Polyphor Ltd. at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Hungary, Germany, United Kingdom, Austria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LVEF (left ventricular ejection fraction) as determined by MRI (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.