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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:
ClinicalTrials.gov Identifier:
NCT00320502
First Posted: May 3, 2006
Last Update Posted: August 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Synvista Therapeutics, Inc
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00320502     History of Changes
Other Study ID Numbers: BXT-203
First Submitted: April 30, 2006
First Posted: May 3, 2006
Last Update Posted: August 25, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases