Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)

This study has been terminated.

(Protocol-defined outcome in terms of efficacy would not be achieved.)

Sponsor:

Information provided by:

Sarepta Therapeutics

ClinicalTrials.gov Identifier:

NCT00451256

First received: March 21, 2007

Last updated: July 6, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 21, 2007
Last Updated Date	July 6, 2009
Start Date ^ICMJE	March 2007
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2007)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00451256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2007)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)
Official Title ^ICMJE	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
Brief 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. 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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Cardiovascular Disease Coronary Artery Bypass
Intervention ^ICMJE	Drug: AVI-5126
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	600
Completion Date	March 2009
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Ukraine

Administrative Information
NCT Number ^ICMJE	NCT00451256
Other Study ID Numbers ^ICMJE	AVI-5126-25
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Sarepta Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sarepta Therapeutics
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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