A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis

NCT00244647 | Terminated Phase 1

• 1 other identifier: AVI-4126-CL-06
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 has 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, pharmacokinetics and potential effectiveness of a single intravenous slow-push dose of RESTEN-MP at the time of stent placement to reduce in-stent restenosis following balloon angioplasty and stent placement. The post-dose follow-up period is up to six-months.

Conditions

Coronary Artery Disease; Coronary Stent Restenosis

Keywords

restenosis; in-stent restenosis

Outcome Measures

Primary Outcomes (1)

• Safety of a single IV slow-push injection of RESTEN-MP administered at the time of Taxus Express™ placement and over a six month surveillance period.

Secondary Outcomes (2)

• Pharmacokinetics of AVI-4126 when administered as RESTEN-MP.

• Evidence of efficacy, based on coronary angiography and IVUS criteria for neointimal hyperplasia and restenosis changes over a 6-month period.

Interventions

RESTEN-MP DRUG

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 19 and ≤ 80 years of age.
• The Subject must be properly consented following FDA regulations and guidelines.
• Male and Female volunteers with reproductive or childbearing potential must agree to practice adequate birth control methods to protect themselves and partners from conception .
• Subjects will be scheduled for percutaneous coronary intervention (PCI) due to first time implantation of a Taxus Express stent as a result of stenosis.
• Subject is an acceptable candidate for coronary artery bypass surgery.
• The Subject has no more than two lesions within the coronary arterial system requiring stent placement where the diameter of the affected artery or arteries is
• ≥ 2.5 mm and ≤ 4.9 mm based on angiography.
• The target lesion (and the secondary lesion, if applicable) is ≤ 20 mm in length via angiography.
• The Subject has had successful placement of a Taxus Express intracoronary stent(s).
• Subject agrees and is able to return for the scheduled study visits.

You may not qualify if:

• One or more treatable lesions within the coronary arterial system requiring planned or staged intervention prior to the Month One visit.
• Multi-vessel coronary artery disease involving more than 2 vessels within the coronary arterial system requiring stent placement.
• Clinically significant findings for any body system that the Principal Investigator determines will exclude a Subject from safely participating in the study.
• A pregnant or nursing female.
• Positive history for HIV, HBV or HCV.
• In-stent restenosis in the target vessel.
• A target lesion located in an unprotected left main coronary artery or aorto-ostial location or in a bypass graft.
• Left ventricular ejection fraction \< 30%.
• Angiographic evidence of the target vessel segment angulated ≥ 45º.
• Angiographic evidence of thrombus or severe calcification in the target lesion.
• History of bleeding disorders or coagulopathy.
• NYHA Class III congestive heart failure (CHF).
• Serum creatinine \> 1.5 mg/dL.
• Clinically active cancer or any medical condition that may lead to study non-compliance or early study termination, confound the results, or is associated with limited life expectancy, i.e., less than 1 year.
• History of a stroke or trans-ischemic attack (TIA) within 6 months of angioplasty.

Sponsors & Collaborators

• Sarepta Therapeutics, Inc.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Thomas Porter, M.D.

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: August 1, 2003
• Last Updated: April 10, 2008

Record last verified: 2008-04