ST-elevation Myocardial Infarction Clinical Trial
Official title:
MINeralocorticoid Receptor Antagonist Pretreatment to MINIMISE Reperfusion Injury After ST-Elevation Myocardial Infarction (STEMI)
Heart attacks, or myocardial infarcts, are a major cause of death and disability in the UK.
Immediate unblocking of the obstructed heart vessel with a balloon catheter and implantation
of a mesh scaffold (stent) in heart centers is warranted in these patients. Morbidity and
mortality in this patient group is related to the infarct size. Therefore, there is a need
to discover novel therapeutic agents which reduce myocardial infarct size and preserve the
contractile heart function.
Large trials involving several thousand patients have demonstrated a survival benefit in
patients with impaired heart function due to a heart attack, who received a
mineralo-corticoid receptor antagonist (MRA, drug name: spironolactone). In these trials
patients received the drug late, 3-14 days after the heart attack.
Our proposal is to investigate whether MRA therapy administered intravenously prior to
unblocking an occluded heart vessel, can reduce infarct size and as such can prevent long
term sequelae of heart attacks.
150 patients admitted to 4 tertiary care hospitals (Heart Hospital London, London Chest,
Essex Cardiothoracic Center and Leeds General Infirmary) for heart attack will be randomly
assigned to receive MRA treatment or placebo. The first dose of the MRA will be applied
intravenously immediately in the catheter suite, even before re-opening of the occluded
vessel. From the second day on, patients will be prescribed oral MRA treatment, as a pill,
for a total of three months. Before hospital discharge and after three months, a magnetic
resonance image (MRI) of the heart will accurately investigate the evolution of infarct
(scar) size and the contractile heart function and compare the group of patients who
received the MRA drug versus the placebo control group. Of note, patients with an ejection
fraction <40% AND signs of heart failure OR diabetes will go on open label eplerenone
according to current guidelines, instead of the study drug.
This study will give first evidence, if very early MRA treatment improves heart function and
should be used as early as possible for treatment of patients after a heart attack.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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