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

NCT00451256 | Terminated Phase 2 DMC

• 1 other identifier: AVI-5126-25
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Coronary Artery Bypass

Keywords

coronary artery bypass; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

AVI-5126 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarepta Therapeutics, Inc.: lead

Study Sites (1)

Unknown Facility

Kiev, Ukraine

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

AVI-5126

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 23, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

UA (1)