Status:
TERMINATED
Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
Lead Sponsor:
Sanofi
Conditions:
AMI
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
Primary objective: To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00670228
Start Date
April 1 2008
End Date
November 1 2009
Last Update
February 11 2011
Active Locations (5)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
São Paulo, Brazil
4
Sanofi-Aventis Administrative Office
Laval, Canada