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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Infarct Size Absolute Change From Baseline at Day 60
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intensive Insulin Therapy (IIT)
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL.
干预措施: Insulin Glargine (LANTUS) (Drug)
Intensive Insulin Therapy (IIT)
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL.
干预措施: Insulin Glulisine (Apidra) (Drug)
Standard Glycemic Care (SGC)
In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
干预措施: Standard Therapy (Drug)
结局指标
主要结局
Infarct Size Absolute Change From Baseline at Day 60
时间窗: From baseline at Day 60
Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.
次要结局
- Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)(At Day 3)
- Occurrence of the Major Adverse Cardiovascular Events (MACE)(At Day 60)
- Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)(At Day 60)