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
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