Resumen

Primary objective: To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC). Secondary objectives: To demonstrate that tight glycemic control using insulin glulisine and insulin glargine reduces markers of inflammation and improves Left Ventricular (LV) function and Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI undergoing Percutaneous Coronary Intervention (PCI).

Elegibilidad

Edad mínima: 35 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Men or women = or \> 35 years of age presenting to the hospital with hyperglycemia (plasma glucose \>140 mg/dL) and Primary Anterior wall ST-Elevation Myocardial Infarction (AW STEMI)
No history of illicit drug abuse in past year
A minimum of 30 minutes but \< or = 6 hours of continuous pain/symptoms immediately prior to presentation
Subjects who will undergo primary percutaneous coronary intervention (PCI)
At least 2 contiguous precordial leads demonstrating at least 2 mm of ST-segment elevation consistent with anterior wall MI
Signed informed consent and HIPAA documentation (US only) prior to participation in the study
Subjects ability and willingness to adhere to and be compliant with study protocol

Criterios de exclusión

A prior history of Myocardial Infarction (MI)
Subjects who have received any thrombolytic therapy during the current hospital admission
Severe Heart Failure or cardiogenic shock (Killip class 3 or 4) by history or present at the time of screening
Subjects with a plasma glucose \>400 mg/dL or diabetic ketoacidosis (DKA)
History of Type 1 diabetes
Active bleeding
Active malignancy, chronic or other medical conditions likely to result in death over the next one year
Recent hypotension requiring inotropic support in the past 30 days
Participation in another clinical research study in the past 30 days
Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
Unwilling to give informed consent
Subjects directly involved in the conduct of the study
Known hypersensitivity to insulin glargine or glulisine
Contraindication to MRI: a)Intracranial aneurysm clips (Unless the investigator is certain that it is made of non-ferromagnetic material such as titanium)b)Intra-orbital metal fragments c)Any electrically, magnetically or mechanically activated implants (including cardiac pacemakers, biostimulators, neurostimulators, cochlear implants, and hearing aids) d)Warning about Gadolinium-based contrast agents (GBCAs) Exposure to GBCAs increases the risk for nephrogenic systemic fibrosis (NSF). Therefore the following subjects should be excluded from the trial based on a history and/or laboratory tests:
acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2), as calculated by the MDRD (Modification of diet in Renal Disease) equation, or
acute renal insufficiency of any severity
Subjects with blood pressure \> or = to 200/110 mmHg at time of randomization
Subjects with a high degree of non-transient AV (Atrio-Ventricular) block
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Intervenciones

drug

Insulin Glargine (LANTUS)

Subcutaneous insulin glargine was initiated 90 prior to the insulin glulisine infusion discontinuation (i.e. 48 hours after randomization) and titrated as per physician preference to maintain the plasma glucose between 90-130 mg/dL

drug

Insulin Glulisine (Apidra)

Prior PCI, subjects received a single IV bolus of insulin glulisine. The dose was 0.025 U/kg based upon patient reported weight. Then IV insulin glulisine infusion was started within one hour of the IV insulin glulisine bolus and administered at a minimum rate of 2 U/h for 48 hours. The infusion was titrated in order to achieve and maintain the plasma glucose between 90 and 130 mg/dL.

drug

Standard Therapy

Standard insulin therapy titrated to blood sugar control

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Insulin Glargine (LANTUS)

Insulin Glulisine (Apidra)

Standard Therapy

Ubicaciones

Sanofi-Aventis Administrative Office

Patrocinadores