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: March 25, 2015
Last verified: March 2015
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • Cardiac Death or Myocardial Infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.


Secondary Outcome Measures:
  • Incremental Rate of Stent Thrombosis (Protocol Definition) [ Time Frame: 1-2 years ] [ Designated as safety issue: Yes ]

    Stent Thrombosis (protocol definition):

    The occurrence of any of the following:

    1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:

      Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion

    2. Acute MI in the distribution of the treated vessel.
    3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.

  • Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations

  • Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
    • Binary rate

  • Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
    • Binary rate

  • Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.

  • Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
    • Binary rate

  • Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
    • Binary rate

  • Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
    • Binary rate

  • Rate of Major Adverse Cardiac Events (MACE): Study Stent Related [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
    • Binary rate

  • Rate of Major Adverse Cardiac Events (MACE): Study Stent Related [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
    • Binary rate

  • Rate of Target Vessel Failure (TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.
    • Binary Rate

  • Rate of Target Vessel Failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.
    • Binary rate

  • Rate of Cardiac Death or Myocardial Infarction (MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    - Binary Rate

  • Rate of Cardiac Death or Myocardial Infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    - Binary Rate

  • Rate of All Cause Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of All Cause Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Cardiac Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Cardiac Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Cardiac Death: Study Stent Related [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Cardiac Death: Study Stent Related [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Myocardial Infarction (MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Myocardial Infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Myocardial Infarction (MI): Study Stent Related [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Myocardial Infarction (MI): Study Stent Related [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    -Binary rate

  • Rate of Target Vessel Reintervention (TVR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    -Binary rate

  • Rate of Target Vessel Reintervention (TVR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    -Binary rate

  • Rate of Target Vessel Reintervention (TVR): Study Stent Related [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    -Binary rate

  • Rate of Target Vessel Reintervention (TVR): Study Stent Related [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    -Binary rate

  • Rate of Stroke [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    -Binary Rate

  • Rate of Stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    -Binary Rate

  • Rate of Major Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
    • Binary rate

  • Rate of Major Bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
    • Binary rate

  • Rate of Stent Thrombosis (ARC Definite + Probable) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • ARC - Academic Research Consortium
    • Binary rate

  • Rate of Stent Thrombosis (ARC Definite + Probable) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • ARC - Academic Research Consortium
    • Binary Rate

  • Rate of Stent Thrombosis (Protocol Definition) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    -Binary rate

    The occurrence of any of the following:

    1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:

      Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion

    2. Acute MI in the distribution of the treated vessel.
    3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.

  • Rate of Stent Thrombosis (Protocol Definition) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    -Binary rate

    The occurrence of any of the following:

    1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:

      Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion

    2. Acute MI in the distribution of the treated vessel.
    3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.


Enrollment: 4199
Study Start Date: December 2009
Estimated Study Completion Date: August 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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: placebo
    Oral placebo to match both 10mg and 5mg prasugrel tablets.
    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 3 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. 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
Sampling Method:   Non-Probability Sample
Study Population

All-comers study with follow-up through 3 years.

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

Publications:
Lee DP, Paulus R, Giri K, Carr J, Baran KW, Hassel D, Winters KJ, Christen T, Dawkins KD, Garratt KN. TCT-167 Primary endpoint results of the TAXUS Libertē post-approval study. Journal of the American College of Cardiology. 2013;62:B54-B54
Garratt, KN, Lambert C, Kabour A, Stewart M, Hall P, Phillips WJ, Winters KJ, Christen T, Dawkins KD, Lee DP TCT-148 TAXUS Liberté PES With ASA + Prasugrel Is Associated With Low TVF, Bleeding And Adverse Event Rates Among Diabetic Patients With "On-Label" Stent Indications. Journal of the American College of Cardiology, 2013; 62 (18_S1): B47-B47.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: March 13, 2014
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Paclitaxel
Prasugrel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on July 29, 2015