Acute Coronary SyndromePhase 2NCT00320502
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
A Phase 2 study testing BXT-51072 in people with Acute Coronary Syndrome and Type 2 Diabetes, run by Synvista Therapeutics, Inc at 4 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Type 2 Diabetes
- What is being tested?
- BXT-51072
- How many people
- 60 participants
- Where
- 4 sitesIsrael
- Study dates
- May 2006to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days
Who cannot join
- CK-MB above normal
- Elevated troponin not showing a decreasing value
- Congestive heart failure
- Atrial fibrillation or left bundle branch block
- Uncontrolled diabetes
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Rambam Medical Center
Haifa, 31096
Western Galilee Hospital
Nahariya, 22100
Rivka Sieff Hospital
Safed, 13100
Sourasky Medical Center
Tel Aviv, 64239
About this study
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
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Type 2 Diabetes
- Being tested
- BXT-51072
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXT-51072Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CK-MB
Safety
Secondary outcomes (2)
Change in troponin
Myocardial ischemia by 24-hour continuous 12-lead ECG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synvista Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shmuel Banai, MD, Principal investigator, Sourasky Medical Center, Tel Aviv, IsraelAriel Roguin, MD, PhD, Principal investigator, Rambam Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320502
- Sponsor's protocol ID
- BXT-203
- Status last verified
- Aug 2008
- First submitted
- 30 Apr 2006
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00320502
- Acronym / sponsor ID
- BXT-203
- Conditions
- Acute Coronary Syndrome, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Synvista Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days
Key exclusion criteria (5 listed)
- CK-MB above normal
- Elevated troponin not showing a decreasing value
- Congestive heart failure
- Atrial fibrillation or left bundle branch block
- Uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXT-51072 | Drug | – |
Primary outcome
Change in CK-MB
Safety
2 secondary outcomes
Change in troponin
Myocardial ischemia by 24-hour continuous 12-lead ECG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Banai, MD principal investigator
Sourasky Medical Center, Tel Aviv, Israel
Ariel Roguin, MD, PhD principal investigator
Rambam Medical Center, Haifa, Israel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BXT-51072 in people with Acute Coronary Syndrome and Type 2 Diabetes, run by Synvista Therapeutics, Inc at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CK-MB. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.