A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)

This study has been completed.
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00320502
First received: April 30, 2006
Last updated: August 21, 2008
Last verified: August 2008

April 30, 2006
August 21, 2008
May 2006
March 2008   (final data collection date for primary outcome measure)
  • Change in CK-MB
  • Safety
Same as current
Complete list of historical versions of study NCT00320502 on ClinicalTrials.gov Archive Site
  • Change in troponin
  • Myocardial ischemia by 24-hour continuous 12-lead ECG
Same as current
Not Provided
Not Provided
 
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Type 2 Diabetes
Drug: BXT-51072
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00320502
BXT-203
No
Not Provided
Synvista Therapeutics, Inc
Not Provided
Principal Investigator: Shmuel Banai, MD Sourasky Medical Center, Tel Aviv, Israel
Principal Investigator: Ariel Roguin, MD, PhD Rambam Medical Center, Haifa, Israel
Synvista Therapeutics, Inc
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP