NCT00093223

Brief Summary

This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the trial is to determine the appropriate dose of the new medicine for future trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

6.3 years

First QC Date

October 4, 2004

Last Update Submit

November 14, 2019

Conditions

Angina PectorisCoronary Artery Disease

Keywords

In-Stent Restenosis

Outcome Measures

Primary Outcomes (3)

  • Incidence of treatment-emergent adverse events and serious adverse events.

    6 months

  • Major Adverse Cardiac Events at 2 months following the stent procedure.

    2 months

  • Safety and tolerability for ABI-007

    2 Years

Secondary Outcomes (1)

  • Evaluation of restenosis at 6 months.

    6 months

Study Arms (2)

1

EXPERIMENTAL

35mg/m\^2 infusion time is 3.5 minutes

Drug: Paclitaxel Nanoparticle Albumin Bound

2

EXPERIMENTAL

2 doses of 35mg.m\^2 with the second dose given 2 months later

Drug: Paclitaxel Nanoparticle Albumin Bound

Interventions

Paclitaxel Nanoparticle Albumin BoundDRUG

Single or duel doses of 35mg/m\^2 ABI-007, administered IV, administered after placement of denovo stent(s).

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries
  • Diagnosis of angina pectoris
  • At least 18 yrs old
  • If female, negative pregnancy test, non-lactating, and agree to utilize methods to prevent pregnancy
  • No previous treatment for In-Stent Restenosis
  • Patient agrees to comply with follow-up evaluation
  • Informed Consent obtained
  • Target vessel at least 3 mm diameter
  • Total stent less than 25 mm
  • Left ventricular ejection fraction at least 30%
  • No more than a single stent will be used per lesion
  • No more than one stented lesion per vessel with the exception that 2 lesions in a single vessel are allowable if covered by less than 25 mm of continuous stent
  • By Intravascular Ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 3 mm or an in-stent luminal area of at least 7 mm2
  • TIMI 3 coronary flow post-stenting
  • No angiographic evidence of thrombus post-stenting

You may not qualify if:

  • More than two lesions treated with Percutaneous Coronary Intervention (PCI) or it is anticipated that additional lesions will require treatment within two months
  • Previous PCI within preceding three months
  • Previous participation in another study within 30 days
  • Life expectancy less than 12 months
  • Factors making follow-up difficult
  • Intended surgical intervention within 6 months of study participation
  • Investigator decision that patient is unsuitable
  • Recipient of heart transplant
  • Q wave or non-Q wave Myocardial Infarction (MI) with documented total CK greater than 2X normal upper limits within the preceding 24 hrs and the CK and CK-MB enzymes remain above normal at the time of the procedure
  • Cardiogenic shock
  • May refuse blood transfusion
  • Gastro-intestinal bleeding within past 3 months
  • Platelet count less than 100,000 cells/mm3
  • Impaired renal function
  • Known allergies/hypersensitivity to aspirin, clopidogrel bisulfate, and/or stainless steel
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abraxis BioScience, Inc.

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Angina PectorisCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • José Iglesias, MD

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2004

First Posted

October 7, 2004

Study Start

September 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

US(1)