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

Primary Purpose

Acute Coronary Syndrome, Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

BXT-51072

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rambam Medical Center
Western Galilee Hospital
Rivka Sieff Hospital
Sourasky Medical Center

Outcomes

Primary Outcome Measures

Change in CK-MB

Safety

Secondary Outcome Measures

Change in troponin

Myocardial ischemia by 24-hour continuous 12-lead ECG

Full Information

NCT ID

NCT00320502

First Posted

April 30, 2006

Last Updated

August 21, 2008

Sponsor

Synvista Therapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00320502

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Synvista Therapeutics, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

BXT-51072

Primary Outcome Measure Information:

Title

Change in CK-MB

Title

Safety

Secondary Outcome Measure Information:

Title

Change in troponin

Title

Myocardial ischemia by 24-hour continuous 12-lead ECG

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shmuel Banai, MD

Organizational Affiliation

Sourasky Medical Center, Tel Aviv, Israel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ariel Roguin, MD, PhD

Organizational Affiliation

Rambam Medical Center, Haifa, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Western Galilee Hospital

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

Rivka Sieff Hospital

City

Safed

ZIP/Postal Code

13100

Country

Israel

Facility Name

Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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