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

Synvista Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome; Type 2 Diabetes

Treatments: Drug: BXT-51072

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320502

BXT-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind