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

Phase 2

Completed

• Conditions: Acute Coronary Syndrome; Type 2 Diabetes

• Registration Number: NCT00320502
• Lead Sponsor: Synvista Therapeutics, Inc

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.

Study Timeline

• Study First Submitted: 2006-04-30
• Study Start: 2006-05
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Primary Completion: 2008-03
• Status Verified: 2008-08
• Study Completion: 2008-08
• Last Update Submitted: 2008-08-21
• Last Update Posted: 2008-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in CK-MB
Safety

Secondary Outcome Measures

Name	Time	Method
Change in troponin
Myocardial ischemia by 24-hour continuous 12-lead ECG

Trial Locations

Locations (4)

Western Galilee Hospital; 🇮🇱 Nahariya, Israel

Rivka Sieff Hospital; 🇮🇱 Safed, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel