A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
NCT ID: NCT00320502
Last Updated: 2008-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2006-05-31
2008-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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BXT-51072
Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days
Exclusion Criteria
* Elevated troponin not showing a decreasing value
* Congestive heart failure
* Atrial fibrillation or left bundle branch block
* Uncontrolled diabetes
30 Years
75 Years
ALL
No
Sponsors
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Synvista Therapeutics, Inc
INDUSTRY
Principal Investigators
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Shmuel Banai, MD
Role: PRINCIPAL_INVESTIGATOR
Sourasky Medical Center, Tel Aviv, Israel
Ariel Roguin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rambam Medical Center, Haifa, Israel
Locations
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Rambam Medical Center
Haifa, , Israel
Western Galilee Hospital
Nahariya, , Israel
Rivka Sieff Hospital
Safed, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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BXT-203
Identifier Type: -
Identifier Source: org_study_id