Coronary Artery Disease Clinical Trial
Official title:
APPRAISAL Trial: A Phase IIa Study to Evaluate the Safety and Preliminary Efficacy of RESTEN-MP® When Used in Conjunction With a Bare Metal Stent in de Novo Native Coronary Artery Lesions
The process of re-narrowing of a coronary artery following a revascularization procedure
such as angioplasty, begins at the time of the procedure. Restenosis has long been
considered a major problem for effective long-term interventional success. This often
results in repeated procedures to deal with recurrent stenosis (or restenosis) of the
original targeted vessel.
There is a substantial body of literature suggesting that local MYC protein production in
the injured coronary artery is a major stimulus and potential cause of restenosis that
appears after stent placement. This study is based upon the hypothesis that stopping MYC
protein production in the vessel will help reduce restenosis (vessel re-narrowing).
AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that
interferes with MYC production.
This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce
in-stent restenosis following balloon angioplasty and stent placement. The post-dose
follow-up period is up to six-months.
RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery,
and again 24 hours later, via slow-push intravenous administration.
The process of restenosis, the re-narrowing of a coronary artery lumen following a
revascularization procedure, begins at the time of percutaneous coronary intervention (PCI).
Restenosis has long been seen as a major impediment of effective long-term interventional
cardiology, necessitating repeated procedures to deal with in situ recurrent stenosis of the
original targeted vessel. The restenosis rates are between 30 to 50% of patients treated
with balloon angioplasty and between 15 to 30% of patients treated with bare metal stents.
There is currently high enthusiasm for drug-eluting stents already approved for the market
and which have an overall restenosis rate of < 3% as reported in published reports for most
clinical trial patient populations. However, there are subsets of patients (e.g., diabetic
patients and patients with diffuse small vessel disease) that have restenosis rates around
10% despite the use of drug-eluting stents. It is probably too early to conclude that the
currently approved drug-eluting stents are a panacea to relieve coronary arterial
obstruction due to atherosclerotic heart disease. In fact, with the increased usage of the
current drug-eluting stents on the market, there are reports of problems such as late stent
malposition, subacute and late thromboses, and aneurysm formations due to the vessel
toxicity associated with this method of treatment. There remains a definite need for a
simple, safe and durable solution to restenosis.
The development of devices such as intravascular ultrasound has led to a greater
understanding of restenosis mechanisms, especially after coronary artery stenting. It is
presumed that the pathogenesis of coronary artery restenosis after a revascularization
procedure entails two major processes. The first component (viz., recoil and remodeling)
involves the mechanical collapse and constriction of the treated vessel; however, coronary
stents provide luminal scaffolding that eliminates recoil and remodeling. The second
component of coronary artery restenosis after a revascularization procedure is the
endothelial response to injury. Whereas, the former focus in modulating the
pathophysiological mechanisms involved in restenosis centered mainly on inhibition of
platelet aggregation and function, current targets of pharmaceutical agents for this
condition have shifted to inhibitors of the cell cycle, smooth muscle cell proliferation and
migration, synthesis of extra-cellular matrix, and inflammatory mediators. Many different
agents are currently being evaluated in pre-clinical and clinical studies.
AVI-4126, the active ingredient of RESTEN-MP, is a proprietary antisense drug designed to
interrupt the translation of the human <c-myc> gene by mRNA. Therefore, the basis for this
study is to ascertain if RESTEN-MP is safe and has a therapeutic benefit. Slow-push
intravenous administration of RESTEN-MP in pharmacological doses in the restenosis porcine
model prevented subsequent in-stent stenosis.
This clinical study will evaluate the safety and potential effectiveness of RESTEN-MP to
reduce in-stent restenosis following balloon angioplasty. In order to objectively assess the
therapeutic value of RESTEN-MP compared to other drugs used in combination with coronary
artery stents and to utilize a sensitive method to assess the effectiveness of RESTEN-MP as
a neointimal hyperplasia inhibitor, late loss between the time of stent placement and 6
months later is the therapeutic endpoint in this study.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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