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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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BXT-51072

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synvista Therapeutics, Inc

INDUSTRY

Sponsor Role lead

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

Site Status

Western Galilee Hospital

Nahariya, , Israel

Site Status

Rivka Sieff Hospital

Safed, , Israel

Site Status

Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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BXT-203

Identifier Type: -

Identifier Source: org_study_id