A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00320502|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : August 25, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Type 2 Diabetes||Drug: BXT-51072||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||August 2008|
- Change in CK-MB
- Change in troponin
- Myocardial ischemia by 24-hour continuous 12-lead ECG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320502
|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|