NCT00320502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

April 30, 2006

Last Update Submit

August 21, 2008

Conditions

Acute Coronary SyndromeType 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Change in CK-MB

  • Safety

Secondary Outcomes (2)

  • Change in troponin

  • Myocardial ischemia by 24-hour continuous 12-lead ECG

Interventions

BXT-51072DRUG

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days

You may not qualify if:

  • CK-MB above normal
  • Elevated troponin not showing a decreasing value
  • Congestive heart failure
  • Atrial fibrillation or left bundle branch block
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rambam Medical Center

Haifa, 31096, Israel

Location

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Rivka Sieff Hospital

Safed, 13100, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Acute Coronary SyndromeDiabetes Mellitus, Type 2

Interventions

BXT 51072

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shmuel Banai, MD

    Sourasky Medical Center, Tel Aviv, Israel

    PRINCIPAL INVESTIGATOR

  • Ariel Roguin, MD, PhD

    Rambam Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 30, 2006

First Posted

May 3, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2008

Study Completion

August 1, 2008

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

IL(4)