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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
History of Changes
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Type 2 Diabetes
 Drug: BXT-51072
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:
  • Change in CK-MB
  • Safety

Secondary Outcome Measures:
  • Change in troponin
  • Myocardial ischemia by 24-hour continuous 12-lead ECG

Estimated Enrollment: 60
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320502

Locations
Israel
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
Sponsors and Collaborators
Synvista Therapeutics, Inc
Investigators
Principal Investigator: Shmuel Banai, MD Sourasky Medical Center, Tel Aviv, Israel
Principal Investigator: Ariel Roguin, MD, PhD Rambam Medical Center, Haifa, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00320502     History of Changes
Other Study ID Numbers: BXT-203
Study First Received: April 30, 2006
Last Updated: August 21, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013