Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery (MAPSS)
2015年5月7日 更新者：Duke University
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels.
In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery.
The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment.
This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).
研究概览
详细说明
This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes.
Approximately 74 subjects will be randomized and complete the study.
研究类型
介入性
注册 (实际的)
12
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35211
- Cardiology, PC
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Birmingham、Alabama、美国、35243
- Cardio-Thoracic Surgeons PC
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Huntsville、Alabama、美国、35801
- Heart Center Research, LLC
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Arkansas
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Fort Smith、Arkansas、美国、72901
- Sparks Regional Medical Center
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Little Rock、Arkansas、美国、72205
- Arkansas Cardiology, PA
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California
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Palo Alto、California、美国、94304
- Stanford University Medical Center
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Georgia
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Atlanta、Georgia、美国、30308
- Emory University Hospital Midtown
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center (DUMC)
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Virginia
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Richmond、Virginia、美国、23225
- Chippenham Medical Center
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West Virginia
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Charleston、West Virginia、美国、25304
- Charleston Area Medical Center (CAMC)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.
- Stable doses of oral antihyperglycemic agents for at least 2 months
- Stable dose of chronic insulin therapy for at least 2 months
- HbA1c documented within 3 months before study enrollment
- Planned first elective coronary artery bypass graft (CABG) surgery
Exclusion Criteria:
- Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
- Receiving incretin therapy or having received incretin therapy within the previous 2 months
- Type 1 DM or a history of ketoacidosis
- Women who are pregnant or breastfeeding
- Known end-stage Kidney disease
- Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4) inhibitor
- Clinically apparent liver disease
- History of pancreatitis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Saxagliptin
Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
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one 5-mg saxagliptin tablet daily
其他名称：
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安慰剂比较：Placebo
Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
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5mg placebo tablet daily
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Troponin I (TnI) Area Under the Curve (AUC)
大体时间：pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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High Sensitive Troponin-I (hsTnT) Area Under the Curve
大体时间：pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve
大体时间：pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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Number of Major Adverse Cardiac Events (MACE)
大体时间：Baseline to end of study (Approximately 35-37 days)
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Death, myocardial infarction (MI), or New congestive heart failure (CHF)
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Baseline to end of study (Approximately 35-37 days)
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Duration of Inotropic Support
大体时间：CABG surg until hosp discharge (Approximately 5 days)
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CABG surg until hosp discharge (Approximately 5 days)
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Number of Participants Who Had an Episode of Hypoglycemia
大体时间：baseline to end of study (Approximately 35-37 days)
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baseline to end of study (Approximately 35-37 days)
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Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support
大体时间：CABG to hospital discharge (Approximately 5 days)
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CABG to hospital discharge (Approximately 5 days)
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Need for Antiarrhythmic Therapy
大体时间：CABG surg to hospital discharge Approximately 5 days
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CABG surg to hospital discharge Approximately 5 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：L. Kristin Newby, M.D., MHS、Duke University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年3月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2013年1月4日
首先提交符合 QC 标准的
2013年1月8日
首次发布 (估计)
2013年1月10日
研究记录更新
最后更新发布 (估计)
2015年5月29日
上次提交的符合 QC 标准的更新
2015年5月7日
最后验证
2015年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.