CATCH-AMI
Research type
Research Study
Full title
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
IRAS ID
126777
Contact name
Jonathan Hill
Contact email
Sponsor organisation
Polyphor AG
Eudract number
2012-003229-91
ISRCTN Number
xx
Research summary
The reduced blood supply to a heart is a main cause of morbidity and mortality worldwide, with a heart attack being the most devastating event.
A heart attack is the pain that patient feels when the heart is starved of oxygen due to a restriction in the flow of blood to the heart muscle. This can lead to long-term damage of the heart muscle following the heart attack and failure of the heart to work efficiently. The body produces cells, known as stem cells, that can travel to the heart and help repair the damage caused by the heart attack. However usually this is insufficient to prevent or reverse the long-term damage.
The medication under evaluation in this clinical study (POL6326) works by increasing the number of stem cells reaching a heart where they may repair more of the damaged tissue and improve the functioning of the heart.A total of approximately 156 people, who have suffered from a heart attack, will participate in this study at multiple locations within Europe.
Participation in this study will involve remaining in hospital for approximately 1 week following emergency admission and then attending 3 outpatient clinic visits over a period of 1 year after a discharge from hospital.
The patient , if eligible and decides to take part in the study, will be given the study drug or placebo on 2 days separated by 48 hours, the first of the two treatments given no greater than 4 days after hospital admission.
There have been no serious or severe adverse events reported that were considered related to the study drug in previous studies
REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/0491
Date of REC Opinion
5 Jun 2013
REC opinion
Further Information Favourable Opinion