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The IMMEDIATE-2 Trial aims to further confirm the promising results from the original IMMEDIATE Trial, supported by NHLBI which was the first double-blind placebo controlled study of GIK for ACS and the first to assess the use of GIK in the pre-hospital setting as administered by paramedics. We believe the IMMEDIATE-2 Trial will conclusively demonstrate that GIK reduces cardiac arrest, infarct size, mortality and heart failure in patients with ACS.




Dates: 2006-2011
Subjects enrolled: 871
Sites: Enrollment occurred across 36 EMS agencies in 13 US cities
Design: Randomized, placebo-controlled, double-blinded effectiveness trial.
Primary Endpoint: Progression of ACS to myocardial infarction within 24 hours.
Secondary Endpoint: Survival at 30 days and a composite of pre-hospital or in-hospital cardiac arrest or in-hospital mortality
Results: Although GIK did not significantly reduce the primary endpoint, progression to AMI, it did significantly reduce the composite endpoint of cardiac arrest or mortality - by 50% for those presenting with suspected ACS, and by 60% for those presenting with ST elevation AMI (STEMI). Also, GIK reduced infarct size by 80%.


Both the original IMMEDIATE Trial and the IMMEDIATE-2 Trial are effectiveness trials. This means that the treatment is tested under real-world conditions and in a broad range of participants and environments that reflect those typically seen in clinical practice. Participants are eligible if they have suspected ACS, rather than only AMI or STEMI as done in previous GIK trials and participating sites are from a variety of rural, urban, large and community hospitals reflecting diverse study population and settings. This differs from a standard efficacy trial that examines the effect of a treatment in optimally selected patients, under advantageous conditions, for short periods, for the purposes of regulatory approval and marketing.


Another key difference between the IMMEDIATE Trial and other GIK trials was the fact that IMMEDIATE was specifically designed to deliver GIK very early in the course of ACS, following 911 calls. Previous GIK trials did not administer GIK until hours after the onset of symptoms, until AMI was diagnosed in the hospital. The median time to treatment from symptom onset in the original IMMEDIATE Trial was 90 minutes, compared with six or more hours in most previous trials. Although previous laboratory studies have shown that early GIK treatment is critical for any physiological benefit, the IMEMDIATE Trial is the only clinical study to focus on this important aspect.


The results of the IMMEDIATE Trial were very encouraging. However, because other prior GIK studies had not been positive - even though they gave GIK later than would be expected to work and had not been double-blind placebo studies such as IMMEDIATE - FDA has requested a confirmatory trial which is why we are mounting IMMEDIATE-2.