Angina Pectoris, Coronary Artery Disease
Conditions
Keywords
In-Stent Restenosis
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.
Detailed description
See inclusion/exclusion criteria.
Interventions
DRUGPaclitaxel Nanoparticle Albumin Bound
Single or duel doses of 35mg/m\^2 ABI-007, administered IV, administered after placement of denovo stent(s).
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Evaluation of restenosis at 6 months. | 6 months |
Countries
United States
Outcome results
None listed