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Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

Information source: Abraxis BioScience Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Restenosis

Intervention: ABI-007 (Drug); ABI-007 (Drug); ABI-007 (Drug); ABI-007 (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Abraxis BioScience Inc.

Official(s) and/or principal investigator(s):
David Hilton, MD, Principal Investigator, Affiliation: Victoria Heart Institute

Summary

The purpose of this study is to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.

Clinical Details

Official title: A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Incidence of any procedural complications

to determine a safe and appropriate intracoronary dose for future clinical trials of ABI-007 administered to patients after successful PTCA and stenting of de novo lesions or angioplasty of ISR lesions

to evaluate the incidence of treatment-emergent adverse events and serious adverse events

Secondary outcome: Restenosis at 6 months

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or non-pregnant and non-lactating female, and ≥ 18 years of age.

- Diagnosis of angina pectoris or unstable angina pectoris or patients with documented

silent ischemia.

- Left ventricular ejection fraction ≥30%

- Patient has undergone successful and uncomplicated stenting of up to 2 de novo lesions

in native coronary arteries OR patient has undergone successful and uncomplicated balloon angioplasty of up to 2 in-stent restenosis (ISR) lesions in native coronary arteries, but not both.

- TIMI 3 coronary flow post-stenting for de novo lesions or post balloon angioplasty for

ISR lesions.

- No angiographic evidence of thrombus post-procedure.

- Target vessel ≥2. 5mm diameter (by angiography).

- Each de novo lesion is such that it is stented with ≤ 25mm of single continuous

stent.

- Each in-stent restenosis (ISR) lesion is ≤ 25mm in length.

- There is at least 5mm of non-diseased vessel on either side of target lesion(s).

- By intravascular ultrasound (IVUS), stent is fully opposed and has a minimum diameter

of 2. 5mm or an in-stent luminal area ≥5. 0mm2

- Patient or guardian has provided a signed written informed consent to participate in

the study and in all follow-up assessments using a form that is approved by the local Institutional Review Board (IRB)/Ethics Committee of the investigative site.

Exclusion Criteria:

- Target de novo lesion was treated with a drug-eluting stent

- Target ISR lesion requires any treatment other than balloon angioplasty

- Patient has both a de novo lesion and an ISR lesion.

- If more than 2 lesions are treated with PCI, or it is anticipated that additional

lesions will require treatment within 2 months.

- Previous percutaneous coronary intervention (PCI) within preceding two months.

- Intended surgical intervention within 6 months of enrollment in the study.

- Unprotected left main disease with >50% stenosis

- Malapposition, dissection, or unmasking of a significant narrowing in the inflow or

outflow area of the implanted stent.

- Women who are pregnant and women of child bearing potential who do not use adequate

contraception

- Previous participation in another study with any investigational drug or device within

the past 30 days or current enrollment in any other clinical protocol or investigational drug or device trial.

- Patient has a life expectancy of less than 12 months or there are factors making

clinical and/or angiographic follow-up difficult

- Any significant medical condition which, in the investigator's opinion, may interfere

with the patient's optimal participation in the study

- Heart transplant candidate or recipient

- Patient is immunosuppressed or is HIV positive.

- Patient has experienced a Q wave or a non Q wave myocardial infarction (MI) with

documented total CK≥2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of the procedure.

- Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80mmHg, with no

response to fluids or SBP less than 100mmHg with vasopressors (in absence of bradycardia)

- Any individual who may refuse a blood transfusion

- Documented major gastro-intestinal bleeding within 3 months

- The following lab values at baseline are exclusionary:

- Serum creatinine > 2. 5 mg/dl;

- Platelet count < 150,000 cells/mm3;

- Absolute neutrophil count (ANC) < 2000 cells/mm3;

- Hemoglobin (HGB) <9g/dl;

- Total bilirubin >1. 5mg/dl;

- ALT (SGPT) > 2. 5 x upper limit of normal range (ULN);

- AST (SGOT) > 2. 5 x upper limit of normal range (ULN);

- Alkaline phosphatase > 2. 5 x upper limit of normal (ULN).

- Known allergy/hypersensitivity/contraindication to the study drug; to any taxanes; or

to any required study treatment: aspirin, clopidogrel bisulfate, stent materials

- Pre-existing peripheral neuropathy of National Cancer Institute (NCI) Toxicity Grade >

1.

Locations and Contacts

Additional Information

Starting date: July 2005
Ending date: May 2009
Last updated: February 29, 2008

Page last updated: June 20, 2008

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