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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BXT-51072 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CK-MB | ||
| Safety |
| Measure | Description | Time Frame |
|---|---|---|
| Change in troponin | ||
| Myocardial ischemia by 24-hour continuous 12-lead ECG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shmuel Banai, MD | Sourasky Medical Center, Tel Aviv, Israel | Principal Investigator |
| Ariel Roguin, MD, PhD | Rambam Medical Center, Haifa, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | 31096 | Israel | |||
| Western Galilee Hospital |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C114695 | BXT 51072 |
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| Nahariya |
| 22100 |
| Israel |
| Rivka Sieff Hospital | Safed | 13100 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |