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Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
This study is ongoing, but not recruiting participants.
Sponsored by: Abraxis BioScience Inc.
Information provided by: Abraxis BioScience Inc.
ClinicalTrials.gov Identifier: NCT00124943
  Purpose

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.


Condition Intervention Phase
Coronary Restenosis
Drug: ABI-007
Phase I
Phase II

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:
  • Incidence of any procedural complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • to evaluate the incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restenosis at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: July 2005
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: ABI-007
10mg/m^2 ABI-007
2: Experimental Drug: ABI-007
22mg/m^2 ABI-007
3: Experimental Drug: ABI-007
35mg^2 ABI-007
4: Experimental Drug: ABI-007
45mg/m^2 ABI-007

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124943

Sponsors and Collaborators
Abraxis BioScience Inc.
Investigators
Principal Investigator: David Hilton, MD Victoria Heart Institute
  More Information

Responsible Party: Abraxis BioScience ( Robert M. Hernandez, PhD/ Clinical Trials Manager )
Study ID Numbers: CVR003
Study First Received: July 27, 2005
Last Updated: February 29, 2008
ClinicalTrials.gov Identifier: NCT00124943  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:
Prevention of Instent Restenosis

Study placed in the following topic categories:
Coronary Disease
Heart Diseases
Paclitaxel
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Coronary Stenosis
Coronary Restenosis
Coronary Artery Disease

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009