A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Change in CK-MB
- Change in troponin
- Myocardial ischemia by 24-hour continuous 12-lead ECG
|Study Start Date:||May 2006|
|Study Completion Date:||August 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Western Galilee Hospital|
|Nahariya, Israel, 22100|
|Rivka Sieff Hospital|
|Safed, Israel, 13100|
|Sourasky Medical Center|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Shmuel Banai, MD||Sourasky Medical Center, Tel Aviv, Israel|
|Principal Investigator:||Ariel Roguin, MD, PhD||Rambam Medical Center, Haifa, Israel|