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Completed

NCT Number: NCT00320502

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Type 2 Diabetes Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rambam Medical Center, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BXT-51072

Drug

Primary outcomes

  1. Change in CK-MB

  2. Safety

Secondary outcomes

  1. Change in troponin

  2. Myocardial ischemia by 24-hour continuous 12-lead ECG

Sponsors and collaborators

Lead sponsor

Synvista Therapeutics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 3, 2006
Registry last updated
Aug 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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