Clinical trial NCT00670228: Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: AMI
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).


Eligibility 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.

Primary outcomes:
measure: Infarct Size Absolute Change From Baseline at Day 60
timeFrame: From baseline at Day 60
Secondary outcomes:
measure: Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)
timeFrame: At Day 3
measure: Occurrence of the Major Adverse Cardiovascular Events (MACE)
timeFrame: At Day 60
measure: Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)
timeFrame: At Day 60
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Study Operations
role: STUDY_DIRECTOR
References: