NCT01905475

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Polyphor Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Large Reperfused ST-Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	POL6326
DRUG	Placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-10-01
• Completion: 2016-06-01
• First posted: 2013-07-23
• Last updated: 2016-06-10

Locations

17 sites across 5 countries: Austria, Germany, Hungary, Poland, United Kingdom