Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
See inclusion/exclusion criteria.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 35mg/m^2 infusion time is 3.5 minutes |
|
| 2 | Experimental | 2 doses of 35mg.m^2 with the second dose given 2 months later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel Nanoparticle Albumin Bound | Drug | Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s). |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of restenosis at 6 months. | 6 months |
Not provided
Inclusion Criteria:
General Exclusion Criteria:
Exclusion Criteria Related to Angioplasty:
Exclusion Criteria Related to ABI-007:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| José Iglesias, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abraxis BioScience, Inc. | Durham | North Carolina | 27703 | United States |
Not provided
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paclitaxel Nanoparticle Albumin Bound | Drug |
|
| Paclitaxel Nanoparticle Albumin Bound | Drug | 35mg/35 infusion time is 3.5 minutes |
|
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |