Cardiovascular DiseasePhase 2NCT00451256
Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)
A Phase 2 study testing AVI-5126 in people with Cardiovascular Disease and Coronary Artery Bypass, run by Sarepta Therapeutics, Inc. at 1 site in Ukraine.
Trial summary
For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage will, after some time, become narrowed and possibly blocked. AVI-5126 blocks a gene that is believed to be responsible for the events in the blood vessel that cause this narrowing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Coronary Artery Bypass
- What is being tested?
- AVI-5126
- How many people
- 600 participants
- Where
- 1 siteUkraine
- Study dates
- Mar 2007to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age
- Subject is a suitable candidate for aortocoronary bypass (CABG) procedure. Subjects undergoing CABG procedure without the use of coronary artery bypass (off pump) are preferred. However, subjects requiring coronary artery bypass will not be excluded from the study
- Female subjects of childbearing potential must have a documented negative serum pregnancy test within 2 days before the CABG procedure
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
Who cannot join
- Subject will have valve replacement or repair during CABG procedure
- Subject has a poor quality donor vessel (poor or turbulent flow, varicose)
- Subject has a known left ventricular ejection fraction of <35%
- Subject has had a percutaneous coronary intervention (PCI) for coronary artery disease treatment 30 days prior to CABG
- Subject has a PCI planned during the 30 days immediately following the CABG procedure
- Subject has chronic atrial fibrillation
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- Subject has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media which cannot be adequately pre-medicated
- Subject has chronic renal insufficiency (i.e., serum creatinine >180 mmol/L) or co-morbid illness which precludes follow-up angiography
- Subject has history of a stroke or transient ischemic attack within the prior 6 months
- Subject has an active peptic ulcer or has had clinically significant upper or lower GI bleeding within the prior 6 months
- Subject has a history of a bleeding diathesis or coagulopathy or will refuse blood transfusions
- Subject has a non-cardiac illness imposing substantial operative mortality
- Subject has a concurrent medical condition resulting in a life expectancy of less than 3 years
- Subject is currently participating in an investigational drug or another device study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Assess the Safety and Efficacy of ex-Vivo Vein Graft Exposure to AVI-5126 in Coronary Artery By-Pass Grafting to Reduce Clinical Graft Failure
For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage will, after some time, become narrowed and possibly blocked. AVI-5126 blocks a gene that is believed to be responsible for the events in the blood vessel that cause this narrowing. Therefore, exposing the vein to AVI-5126 before it is attached to the coronary artery may result in less problems with these vein grafts later on. This study will determine if this procedure is both safe and effective.
Read the detailed description
Coronary artery bypass (CABG) is a common procedure employed for life-threatening cardiovascular disease. While bypass surgery is effective in restoring blood flow in the short-term, 30 to 50 percent of venous bypass grafts eventually become blocked or fail. Within the first year after a CABG procedure, it is estimated that between 15 and 30% of saphenous vein grafts fail (i.e., ≥ 75% reduction in flow within the graft), due to intimal hyperplasia at the anastomosis sites. There is currently no approved treatment to prevent venous graft failure. These patients may frequently undergo a second bypass surgery if the extent of graft failure(s) is sufficiently severe to lead to uncontrolled angina pectoris. It is clear that a second CABG procedure in a patient represents a higher operative mortality rate than the first procedure. Venous graft failure in CABG is a major unmet medical-surgical problem.
AVI has previously focused some of its Neugene® products in the area of preventing cardiovascular stenosis. This application of antisense targeted to to inhibit the c-myc gene has previously been demonstrated to prevent sequelae of intimal hyperplasia following endovascular injury. The purpose of this study is to evaluate whether immersion of the excised saphenous vein in a novel anti-c-myc antisense drug (AVI-5126) solution will prevent subsequent graft failure at 1 year, compared to physiological saline (placebo) prior to graft anastomosis.
- Conditions
- Cardiovascular Disease, Coronary Artery Bypass
- Being tested
- AVI-5126
- Keywords
- coronary artery bypass, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVI-5126Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the safety of 10µM AVI-5126 immersion of excised saphenous vein segments prior to CABG compared to immersion in the Placebo at Day 14 and Months 1, 3, 6, 9, and 12 after CABG.
Secondary outcomes (1)
to evaluate if immersion of excised saphenous vein in 10µM AVI-5126 prior to CABG reduces graft failure when compared to immersion in Placebo 12 months after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2007
- Study completionMar 2009
Why it stopped: Protocol-defined outcome in terms of efficacy would not be achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Sarepta Therapeutics, Inc.The sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarepta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451256
- Sponsor's protocol ID
- AVI-5126-25
- Status last verified
- Jul 2009
- First submitted
- 21 Mar 2007
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Safety and Efficacy of ex-Vivo Vein Graft Exposure to AVI-5126 in Coronary Artery By-Pass Grafting to Reduce Clinical Graft Failure
- ClinicalTrials.gov ID
- NCT00451256
- Acronym / sponsor ID
- AVI-5126-25
- Conditions
- Cardiovascular Disease, Coronary Artery Bypass
- Keywords
- coronary artery bypass, cardiovascular disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol-defined outcome in terms of efficacy would not be achieved.
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sarepta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Mar 2007 (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.
For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage will, after some time, become narrowed and possibly blocked. AVI-5126 blocks a gene that is believed to be responsible for the events in the blood vessel that cause this narrowing. Therefore, exposing the vein to AVI-5126 before it is attached to the coronary artery may result in less problems with these vein grafts later on. This study will determine if this procedure is both safe and effective.
Detailed description
Coronary artery bypass (CABG) is a common procedure employed for life-threatening cardiovascular disease. While bypass surgery is effective in restoring blood flow in the short-term, 30 to 50 percent of venous bypass grafts eventually become blocked or fail. Within the first year after a CABG procedure, it is estimated that between 15 and 30% of saphenous vein grafts fail (i.e., ≥ 75% reduction in flow within the graft), due to intimal hyperplasia at the anastomosis sites. There is currently no approved treatment to prevent venous graft failure. These patients may frequently undergo a second bypass surgery if the extent of graft failure(s) is sufficiently severe to lead to uncontrolled angina pectoris. It is clear that a second CABG procedure in a patient represents a higher operative mortality rate than the first procedure. Venous graft failure in CABG is a major unmet medical-surgical problem.
AVI has previously focused some of its Neugene® products in the area of preventing cardiovascular stenosis. This application of antisense targeted to to inhibit the c-myc gene has previously been demonstrated to prevent sequelae of intimal hyperplasia following endovascular injury. The purpose of this study is to evaluate whether immersion of the excised saphenous vein in a novel anti-c-myc antisense drug (AVI-5126) solution will prevent subsequent graft failure at 1 year, compared to physiological saline (placebo) prior to graft anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is ≥ 18 years of age
- Subject is a suitable candidate for aortocoronary bypass (CABG) procedure. Subjects undergoing CABG procedure without the use of coronary artery bypass (off pump) are preferred. However, subjects requiring coronary artery bypass will not be excluded from the study
- Female subjects of childbearing potential must have a documented negative serum pregnancy test within 2 days before the CABG procedure
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
Key exclusion criteria (14 listed)
- Subject will have valve replacement or repair during CABG procedure
- Subject has a poor quality donor vessel (poor or turbulent flow, varicose)
- Subject has a known left ventricular ejection fraction of <35%
- Subject has had a percutaneous coronary intervention (PCI) for coronary artery disease treatment 30 days prior to CABG
- Subject has a PCI planned during the 30 days immediately following the CABG procedure
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 |
|---|---|---|
| AVI-5126 | Drug | – |
Primary outcome
to evaluate the safety of 10µM AVI-5126 immersion of excised saphenous vein segments prior to CABG compared to immersion in the Placebo at Day 14 and Months 1, 3, 6, 9, and 12 after CABG.
1 secondary outcome
to evaluate if immersion of excised saphenous vein in 10µM AVI-5126 prior to CABG reduces graft failure when compared to immersion in Placebo 12 months after CABG
Results and safety
The study was stopped early (reason given: Protocol-defined outcome in terms of efficacy would not be achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVI-5126 in people with Cardiovascular Disease and Coronary Artery Bypass, run by Sarepta Therapeutics, Inc. at 1 site in Ukraine.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. 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 was stopped early (reason given: Protocol-defined outcome in terms of efficacy would not be achieved.). Results are not available in the source record.
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?
to evaluate the safety of 10µM AVI-5126 immersion of excised saphenous vein segments prior to CABG compared to immersion in the Placebo at Day 14 and Months 1, 3, 6, 9, and 12 after CABG.. 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 8 Jul 2009.