completed
    The objective of the RECREATE pilot study was to evaluate the hypothesis that insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia and result in reduction in cardiovascular events.

    (The pilot was not powered to provide conclusive results on effects of insulin on clinical events. If safe and associated with glucose lowering a full scale trial was planned.)

    Primary endpoint:

    The 24-hour difference in mean glucose between the two study groups.

    Secondary endpoints: The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first); Tthe difference in mean glucose level achieved at 30 days between study groups; nonfatal recurrent myocardial infarction; nonfatal stroke; cardiovascular death (as a composite and as separate outcomes); rehospitalization for congestive heart failure; all-cause mortality; resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes); cardiogenic shock; cardiac procedures; rehospitalization for any cause; symptomatic and severe hypoglycemic episodes; hypokalemic episodes.

    All clinical event endpoints were adjudicated.

Study Type

Interventional - Drug

Study Design

Randomized, open label, placebo control, parallel group

NO. of Countries

3

NO. of Sites

17

NO. of Participants

287

Study Period

2008-2010

Sponsor

PHRI

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