TAXUS Libertē Post Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eli Lilly and Company
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00997503
First received: October 15, 2009
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent
Drug: prasugrel
Drug: placebo
Drug: aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: TAXUS Libertē Post Approval Study: A U.S. Post-Approval Study of the TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Rate of Cardiac Death or Myocardial Infarction in the on-label patient population. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of Stent Thrombosis in the on-label patient population. [ Time Frame: Annually after the first year, for 5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Failure (TVF) rate for TAXUS Liberté on-label medically treated diabetic population. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4200
Study Start Date: December 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 12-Month Dual Antiplatelet Arm
12-months open-label prasugrel & aspirin + an additional 18 months placebo/aspirin (blinded)
Device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent
The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (Liberté Coronary Stent System) and a drug product (a formulation of paclitaxel contained in a polymer coating).The polymer coating serves as a carrier system to provide uniform and controlled biphasic release of the drug into the vessel wall once the stent is deployed.
Drug: placebo
Oral placebo to match both 10mg and 5mg prasugrel tablets.
Drug: aspirin

Oral, as prescribed by physician through end of study.

.

Active Comparator: 30-Month Dual Antiplatelet Arm
12-months open-label prasugrel & aspirin + an additional 18 months prasugrel/aspirin (blinded)
Device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent
The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (Liberté Coronary Stent System) and a drug product (a formulation of paclitaxel contained in a polymer coating).The polymer coating serves as a carrier system to provide uniform and controlled biphasic release of the drug into the vessel wall once the stent is deployed.
Drug: prasugrel
10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure
Other Name: Effient
Drug: aspirin

Oral, as prescribed by physician through end of study.

.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Enrollment Inclusion Criteria

  • Patient is > 18 years of age.
  • Consecutive patients who have signed an Informed Consent Form, who do not otherwise meet applicable exclusion criteria, and who are eligible to receive a TAXUS Liberté Stent and the study required DAPT will be evaluated for enrollment in this study.

Enrollment Exclusion Criteria

  • 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(> 14 days)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).

Additional Exclusion Criteria (applicable only after patient enrollment has reached approximately 3600)

  • Patient who experienced a myocardial infarction (MI) within 72 hours prior to the index procedure.
  • Patient with a history of (includes current) left main coronary artery disease.
  • Patient who requires stenting of > 1 vessel with a TAXUS Liberté stent during the index procedure.
  • Patient who requires stenting of > 2 vessels during the index procedure.
  • Patient who requires a staged procedure within 6-weeks following the index procedure, in whom > 1 vessel was stented during the index procedure.
  • Patient with cardiogenic shock.
  • Patient with acute or chronic renal dysfunction (serum creatinine >3.0 mg/dl or patient receiving dialysis).
  • Target Lesion that meets any of the following criteria:

    • Located within a saphenous vein graft or an arterial graft
    • Chronic total occlusion
    • Restenosis from a previously implanted drug-eluting or bare-metal stent
    • Previous use of intravascular brachytherapy in target vessel
    • Lesion involves a bifurcation
    • Lesion is ostial in location
    • Severe tortuosity in the target lesion or target vessel proximal to the target lesion
    • Moderate or severe calcification by visual estimate in the target lesion or target vessel proximal to the target lesion
    • RVD < 2.5 mm or RVD > 3.75 mm
    • Lesion length > 28 mm

Randomization Inclusion 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, stent thrombosis and/or myocardial infarction occurring within 6 weeks after the index procedure will not be excluded from the definition of 12-Month Clear.
  • Patient was compliant with DAPT during the first 12 months of the study. Compliance is defined as the patient taking between 80% and 120% of prasugrel in the 0-6 month and 6-12 month periods without an interruption of therapy longer than 14 days. Compliance at both time points is required to be considered 12-Month Clear.

Randomization Exclusion Criteria (12-months):

  • 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 (> 14 days) 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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997503

  Show 82 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Investigators
Principal Investigator: David P Lee, MD Stanford University
Principal Investigator: Kirk N Garratt, MD Lenox Hill Hospital
Study Director: Peter M Maurer, MPH Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00997503     History of Changes
Other Study ID Numbers: H7T-MC-TADN, S2035
Study First Received: October 15, 2009
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Prasugrel
Aspirin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014