TAXUS Liberte Post Approval Study
Sponsor: Boston Scientific Corporation, May 2010This study is currently recruiting participants.
The TAXUS LibertÄ“ 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).
|Coronary Artery Disease||Device: TAXUS Liberté Paclitaxel-Eluting|
The TAXUS LibertÄ“ 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. Participating physicians at up to 65 U.S. study centers will each have an opportunity to enroll up to 100 consecutive consented patients who receive a TAXUS Liberté Stent. 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.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: NoCriteria
Enrollment Inclusion Criteria:
- Patient is > 18 years of age.
- Consecutive patients who are eligible to receive a TAXUS Liberté Stent and the study-required DAPT will be evaluated for enrollment in this study.
- The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is currently indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries > or equal to 2.25 mm to < or equal to 4.00 mm in diameter in lesions < or equal to 34 mm in length.
- All patients who have a TAXUS Liberté Stent implant procedure attempted and who have signed the Informed Consent Form will be included until enrollment objectives have been reached.
- Patients in whom the treating physician has determined that the TAXUS Liberté Stent is the most appropriate device even if outside of the approved indication, should also be asked to participate in the study.
Enrollment Exclusion Criteria
Randomization Inclusion Criteria (12-months:
- Patient with known hypersensitivity to paclitaxel or structurally related compounds.
- Patient with known hypersensitivity to the polymer or any of its individual components.
- Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
- Patient who cannot receive the protocol required dual antiplatelet therapy.
- Patient on warfarin or similar anticoagulant therapy.
- Patient with known pregnancy.
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 30-months following enrollment.
- Current medical condition with a life expectancy of less than 3 years.
- Patient currently enrolled in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a drug-eluting stent other than the TAXUS Liberté Stent.
- Patient judged unable to cooperate with prolonged DAPT.
- Patient unable to give informed consent.
- Patient judged inappropriate for randomization due to other condition requiring chronic thienopyridine use.
- Patient treated with both a drug-eluting stent and a bare-metal stent during the index procedure.
- Patient who experienced a prior transient ischemic attack (TIA) or a prior stroke.
- Patient requiring chronic daily use (greater than 2 consecutive weeks) of non-steroidal anti-inflammatory drugs (NSAIDs) with the exception of aspirin. Occasional use of NSAIDs on an as needed or "prn" schedule is not exclusionary.
- Patient with active pathological bleeding (such as peptic ulcer or intracranial hemorrhage).
Randomization Exclusion Criteria (12-months:
- Patient is "12-Month Clear," which is defined as patients enrolled in the study who are free from all death, MI, stroke, repeat coronary revascularization, stent thrombosis and major bleeding (severe or moderate by GUSTO classification) 12 months after stent implantation and who are compliant with 12 months of DAPT following stent implantation. Exceptions to this rule are: Patients who experience repeat PCI and/or peri-procedural myocardial infarction occurring during or within 6 weeks after the index procedure will not be excluded from the definition of 12-Month Clear.
- Known pregnancy.
- Patient switched from prasugrel to other thienopyridine after discharge from index hospitalization.
- Patient switched maintenance dose of prasugrel (such as 10mg to 5mg; or 5mg to 10mg) within 6-months prior to randomization.
- Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
- Patients on warfarin or similar anticoagulant therapy.
- Current medical condition with life expectancy of less than 3 years.
Contacts and LocationsPhysicians:
Ameer Kabour, MD
Tarif Kanaan, MD
Maged Rizk, MD Coordinators:
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC
Julie Neidhardt, RN, BSNPlease contact us at 419-251-4919 for further information about this study.