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Clinical Trial Details

Trial ID: L5278
Source ID: NCT01765270
Associated Drug: Saxagliptin
Title: Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Acronym: MAPSS
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01765270/results
Conditions: Type 2 Diabetes Mellitus|Cardiovascular Disease
Interventions: DRUG: Saxagliptin|DRUG: Placebo
Outcome Measures: Primary: Troponin I (TnI) Area Under the Curve (AUC), pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days) | Secondary: High Sensitive Troponin-I (hsTnT) Area Under the Curve, pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve, pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|Number of Major Adverse Cardiac Events (MACE), Death, myocardial infarction (MI), or New congestive heart failure (CHF), Baseline to end of study (Approximately 35-37 days)|Duration of Inotropic Support, CABG surg until hosp discharge (Approximately 5 days)|Number of Participants Who Had an Episode of Hypoglycemia, baseline to end of study (Approximately 35-37 days)|Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support, CABG to hospital discharge (Approximately 5 days)|Need for Antiarrhythmic Therapy, CABG surg to hospital discharge Approximately 5 days
Sponsor/Collaborators: Sponsor: Duke University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose:
Start Date: 2013-03
Completion Date: 2014-06
Results First Posted: 2015-05-08
Last Update Posted: 2015-05-29
Locations: Cardiology, PC, Birmingham, Alabama, 35211, United States|Cardio-Thoracic Surgeons PC, Birmingham, Alabama, 35243, United States|Heart Center Research, LLC, Huntsville, Alabama, 35801, United States|Sparks Regional Medical Center, Fort Smith, Arkansas, 72901, United States|Arkansas Cardiology, PA, Little Rock, Arkansas, 72205, United States|Stanford University Medical Center, Palo Alto, California, 94304, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Duke University Medical Center (DUMC), Durham, North Carolina, 27710, United States|Chippenham Medical Center, Richmond, Virginia, 23225, United States|Charleston Area Medical Center (CAMC), Charleston, West Virginia, 25304, United States
URL: https://clinicaltrials.gov/show/NCT01765270