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The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen.
This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study).
The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This is a consecutively-enrolled study with patient follow-up through 5 years post index procedure. This study also will contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study). To facilitate this patient data contribution, patients will be assigned to patient groups based upon their co-morbidities and stented lesions identified post index procedure.
All enrolled patients who have been treated with the TAXUS Liberté Stent will be assigned to 12 months of open-label prasugrel treatment and aspirin. Upon completion of the open-label period, patients who are clear of events at 12 months post index procedure will be randomized 1:1 to either a placebo or prasugrel for an additional 18 months of treatment, followed by a 3-month period of observation. After this 3 month observation period, patients may receive open-label thienopyridine of choice at the discretion of the treating physician for the remainder of the study. All patients will receive aspirin therapy throughout the course of the study.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Coronary Artery Disease
TAXUS Liberté Paclitaxel-Eluting Coronary Stent, prasugrel, placebo, aspirin
Baptist Medical Center Princeton
Boston Scientific Corporation
Published on BioPortfolio: 2014-08-27T03:18:34-0400
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Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).
A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.
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