Type 2 Diabetes Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effects of BXT-51072 on CK-MB in High-Risk Type 2 Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a
cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous
intervention (PCI), a procedure to "open" coronary arteries.
BXT-51072 belongs to a class of drugs called "glutathione peroxidase mimics." BXT-51072
works by imitating a substance produced in various tissues in the body, which prevents
damage of the heart and blood vessels.
Following screening, baseline measurements and informed consent, patients will receive
BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then
three times per day for 2 days. There will be 5 treatment visits and 3 follow-up visits.
Blood samples will be obtained for CK-MB, troponin and routine chemistry. A 24-hour
continuous electrocardiogram will be obtained following the PCI and regular
electrocardiograms will be obtained during the study and follow-up period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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