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RECREATE Pilot

Official Title

The RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia)

Status

Completed

Overview

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 is not powered to provide conclusive results on effects of insulin on clinical events; if safe and associated with glucose lowering a full scale trial is planned.

Study Design

Randomized, open label, placebo control, parallel group design.

Primary Endpoint

The primary outcome measure is 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), the difference in mean glucose level achieved at 30 days between study groups, nonfatal recurrent myocardial infarction, nonfatal stroke, or 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 are adjudicated.

Number of Patients

287

Number of Sites

17

Number of Countries

3

Study Period

2008–2010

Principal Investigator

Hertzel Gerstein

Program Manager

Jackie Bosch

Collaborators

Sanofi-Aventis

Key Publications

  • Nerenberg KA, Goyal A, Xavier D, Sigamani A, Ng J, Mehta SR, Díaz R, Kosiborod M, Yusuf S, Gerstein HC; RECREATE Investigators. Piloting a novel algorithm for glucose control in the coronary care unit: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) trial. Diabetes Care. 2012 Jan;35(1):19-24. doi: 10.2337/dc11-0706.