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Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: AMI

Intervention: Insulin Glargine (LANTUS) (Drug); Insulin Glulisine (Apidra) (Drug); Standard Therapy (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Study Operations, Study Director, Affiliation: Sanofi

Summary

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).

Clinical Details

Official title: A Multi-center, Phase 3b, Stratified, Randomized, Open-label Clinical Trial to Evaluate the Efficacy of Intensive Apidra®/Lantus® Therapy vs Sliding Scale Insulin on Infarct Size in Hyperglycemic Subjects With Anterior STEMI (ST Elevation Myocardial Infarction) Undergoing PCI (Percutaneous Coronary Intervention)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Infarct Size Absolute Change From Baseline at Day 60

Secondary outcome:

Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)

Occurrence of the Major Adverse Cardiovascular Events (MACE)

Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)

Eligibility

Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Sanofi-Aventis Administrative Office, Sao Paulo, Brazil

Sanofi-Aventis Administrative Office, Laval, Canada

Sanofi-Aventis Administrative Office, Col. Coyoacan, Mexico

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States

Additional Information

Starting date: April 2008
Last updated: January 14, 2011

Page last updated: August 23, 2015

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