TAXUS Libertē Post Approval Study

NCT ID: NCT00997503

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2015-07-31

Brief Summary

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).

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

prasugrel

10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure

Intervention Type: DRUG

placebo

Oral placebo to match both 10mg and 5mg prasugrel tablets.

Intervention Type: DRUG

aspirin

Oral, as prescribed by physician through end of study.

.

Intervention Type: DRUG

Other Intervention Names

Effient

Eligibility Criteria

Inclusion Criteria

• Patient is > 18 years of age.

• 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.

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).

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David P Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Kirk N Garratt, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital

Peter M Maurer, MPH

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Advanced Cardiac Specialists

Mesa, Arizona, United States

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Baptist Health Medical Center

Little Rock, Arkansas, United States

Bakersfield Memorial Hospital

Bakersfield, California, United States

Bakersfield Heart

Bakersfield, California, United States

Mercy General Hospital

Sacramento, California, United States

Alvarado Hospital

San Diego, California, United States

Stanford University Medical Center

Stanford, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

St. Anthony Central Hospital

Denver, Colorado, United States

Medical Center of the Rockies (Loveland)

Loveland, Colorado, United States

St. Vincent's Medical Center

Bridgeport, Connecticut, United States

Christiana Hospital

Newark, Delaware, United States

JFK Medical Center

Atlantis, Florida, United States

North Florida Regional Medical Center

Gainesville, Florida, United States

Baptist Medical Center

Jacksonville, Florida, United States

Memorial Hospital Jacksonville/ Orange Park Medical Center

Jacksonville, Florida, United States

Holmes Regional Medical Center

Melbourne, Florida, United States

Florida Hospital

Orlando, Florida, United States

Baptist Hospital

Pensacola, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Bayfront Medical Center

St. Petersburg, Florida, United States

Martin Memorial Medical Center

Stuart, Florida, United States

University Community Hospital

Tampa, Florida, United States

Kaiser Foundation Hospitals

Honolulu, Hawaii, United States

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

MacNeal Hospital

Berwyn, Illinois, United States

Jesse Brown VA Medical Center

Chicago, Illinois, United States

IU Health North Medical Center

Carmel, Indiana, United States

Indiana Heart Hospital

Indianapolis, Indiana, United States

King's Daughters Medical Center- Kentucky Heart Institute

Ashland, Kentucky, United States

St. Joseph Hospital

Lexington, Kentucky, United States

Christus St. Frances Cabrini Hospital

Alexandria, Louisiana, United States

Cardiovascular Research, LLC

Shreveport, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Central Maine Medical Center

Lewiston, Maine, United States

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Ingham Regional Medical Center

Lansing, Michigan, United States

Mid Michigan Medical Center

Midland, Michigan, United States

St. Mary's Medical Center

Mount Pleasant, Michigan, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

Covenant Medical Center

Saginaw, Michigan, United States

Lakeland Hospital at St. Joseph

Saint Joseph, Michigan, United States

Providence Hospital

Southfield, Michigan, United States

North Memorial Medical Center

Minneapolis, Minnesota, United States

United Heart and Vascular Clinic

Saint Paul, Minnesota, United States

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Freeman West Hospital

Joplin, Missouri, United States

Cox Medical Centers

Springfield, Missouri, United States

St. John's Mercy Medical Center

St Louis, Missouri, United States

Our Lady of Lourdes Medical Center

Camden, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Heart Hospital of New Mexico

Albuquerque, New Mexico, United States

Maimonides Medical Center

Brooklyn, New York, United States

Lenox Hill Hospital

New York, New York, United States

Columbia University/ New York Presbyterian Hospital

New York, New York, United States

St. Elizabeth Medical Center

Utica, New York, United States

Gaston Memorial Hospital

Gastonia, North Carolina, United States

Wake Medical Center

Raleigh, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Med Central Health System- Mid Ohio Heart Clinic

Mansfield, Ohio, United States

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Conemaugh Valley Memorial Hospital

Johnstown, Pennsylvania, United States

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Palmetto Richland Memorial Hospital

Columbia, South Carolina, United States

Sisters of Charity Providence Hospital

Columbia, South Carolina, United States

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, United States

Jackson Madison County General Hospital

Jackson, Tennessee, United States

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, United States

Doctors Hospital at Renaissance/ McAllen Heart Hospital

Edinburg, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Kingwood Medical Center

Kingwood, Texas, United States

Methodist Texsan Hospital

San Antonio, Texas, United States

Cardiovascular Associates of East Texas Medical Center

Tyler, Texas, United States

Meriter Hospital, Inc.

Madison, Wisconsin, United States

Countries

United States

References

Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation. 1990 Oct;82(4):1193-202. doi: 10.1161/01.cir.82.4.1193.

Reference Type: BACKGROUND

PMID: 2401060 (View on PubMed)

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

Reference Type: RESULT

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.

Reference Type: RESULT

Garratt KN, Weaver WD, Jenkins RG, Pow TK, Mauri L, Kereiakes DJ, Winters KJ, Christen T, Allocco DJ, Lee DP. Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after TAXUS Liberte paclitaxel-eluting coronary stent placement. Circulation. 2015 Jan 6;131(1):62-73. doi: 10.1161/CIRCULATIONAHA.114.013570. Epub 2014 Nov 16.

Reference Type: DERIVED

PMID: 25400062 (View on PubMed)

Other Identifiers

S2035

Identifier Type: OTHER

Identifier Source: secondary_id

H7T-MC-TADN

Identifier Type: -

Identifier Source: org_study_id