Acute Coronary Syndrome, Type 2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBXT-51072
Sponsors
Synvista Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days
Exclusion criteria
* CK-MB above normal * Elevated troponin not showing a decreasing value * Congestive heart failure * Atrial fibrillation or left bundle branch block * Uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CK-MB | — |
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in troponin | — |
| Myocardial ischemia by 24-hour continuous 12-lead ECG | — |
Countries
Israel
Outcome results
None listed