A Safety Study of ABI-007 for In-Stent Restenosis

Completed · Phase 2

Conditions studied: Angina Pectoris, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00093223

Run by

Celgene

People needed

76

Starts

2001-09-01

Expected to finish

2007-12-01

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• General Exclusion Criteria:
• 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

Where it is running

• Abraxis BioScience, Inc. — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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