TAXUS Libertē Post Approval Study
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00997503
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4199
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac Death or Myocardial Infarction 12 months 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
Name Time Method Incremental Rate of Stent Thrombosis (Protocol Definition) 1-2 years 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.Rate of Major Adverse Cardiac Events (MACE) 12 months * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
* Binary rateRate of Stent Thrombosis (ARC Definite + Probable) 12 months * ARC - Academic Research Consortium
* Binary RateTarget Vessel Failure (TVF) for the Medically-Treated Diabetic Population 12 months 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 & Cerebrovascular Events (MACCE): Study Stent Related 6 months MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
Rate of Cardiac Death 12 months -Binary rate
Rate of Myocardial Infarction (MI) 12 months -Binary rate
Rate of Myocardial Infarction (MI): Study Stent Related 12 months -Binary rate
Rate of Target Vessel Reintervention (TVR): Study Stent Related 12 months -Binary rate
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related 12 months * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
* Binary rateRate of Major Adverse Cardiac Events (MACE): Study Stent Related 12 months * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
* Binary rateRate of Target Vessel Failure (TVF) 12 months * 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 rateRate of Target Vessel Reintervention (TVR) 12 months -Binary rate
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) 12 months * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
* Binary rateRate of All Cause Death 12 months -Binary rate
Rate of Stroke 12 months -Binary Rate
Rate of Major Bleeding 12 months * Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
* Binary rateRate of Cardiac Death or Myocardial Infarction (MI) 12 months - Binary Rate
Rate of Cardiac Death: Study Stent Related 12 months -Binary rate
Rate of Stent Thrombosis (Protocol Definition) 12 months -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.
Trial Locations
- Locations (82)
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Advanced Cardiac Specialists
🇺🇸Mesa, Arizona, United States
NEA Baptist Memorial Hospital
🇺🇸Jonesboro, Arkansas, United States
St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
Bakersfield Memorial Hospital
🇺🇸Bakersfield, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Jesse Brown VA Medical Center
🇺🇸Chicago, Illinois, United States
King's Daughters Medical Center- Kentucky Heart Institute
🇺🇸Ashland, Kentucky, United States
Indiana Heart Hospital
🇺🇸Indianapolis, Indiana, United States
Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Mid Michigan Medical Center
🇺🇸Midland, Michigan, United States
St. Mary's Medical Center
🇺🇸Mt. Pleasant, Michigan, United States
Covenant Medical Center
🇺🇸Saginaw, Michigan, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Lakeland Hospital at St. Joseph
🇺🇸St. Joseph, Michigan, United States
Memorial Hospital at Gulfport
🇺🇸Gulfport, Mississippi, United States
Cox Medical Centers
🇺🇸Springfield, Missouri, United States
St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Heart Hospital of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Gaston Memorial Hospital
🇺🇸Gastonia, North Carolina, United States
Wake Medical Center
🇺🇸Raleigh, North Carolina, United States
Med Central Health System- Mid Ohio Heart Clinic
🇺🇸Mansfield, Ohio, United States
Conemaugh Valley Memorial Hospital
🇺🇸Johnstown, Pennsylvania, United States
Palmetto Richland Memorial Hospital
🇺🇸Columbia, South Carolina, United States
Presbyterian University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Grand Strand Regional Medical Center
🇺🇸Myrtle Beach, South Carolina, United States
Jackson Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Doctors Hospital at Renaissance/ McAllen Heart Hospital
🇺🇸Edinburg, Texas, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Cardiovascular Associates of East Texas Medical Center
🇺🇸Tyler, Texas, United States
Alvarado Hospital
🇺🇸San Diego, California, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Memorial Hospital Jacksonville/ Orange Park Medical Center
🇺🇸Jacksonville, Florida, United States
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Bayfront Medical Center
🇺🇸St. Petersburg, Florida, United States
Baptist Hospital
🇺🇸Pensacola, Florida, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Martin Memorial Medical Center
🇺🇸Stuart, Florida, United States
Kootenai Medical Center
🇺🇸Coeur d'Alene, Idaho, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Christus St. Frances Cabrini Hospital
🇺🇸Alexandria, Louisiana, United States
Cardiovascular Research, LLC
🇺🇸Shreveport, Louisiana, United States
Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Our Lady of Lourdes Medical Center
🇺🇸Camden, New Jersey, United States
Sisters of Charity Providence Hospital
🇺🇸Columbia, South Carolina, United States
Avera Heart Hospital of South Dakota
🇺🇸Sioux Falls, South Dakota, United States
Bakersfield Heart
🇺🇸Bakersfield, California, United States
MacNeal Hospital
🇺🇸Berwyn, Illinois, United States
IU Health North Medical Center
🇺🇸Carmel, Indiana, United States
Freeman West Hospital
🇺🇸Joplin, Missouri, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Columbia University/ New York Presbyterian Hospital
🇺🇸New York, New York, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
St. Elizabeth Medical Center
🇺🇸Utica, New York, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Kingwood Medical Center
🇺🇸Kingwood, Texas, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Meriter Hospital, Inc.
🇺🇸Madison, Wisconsin, United States
United Heart and Vascular Clinic
🇺🇸St. Paul, Minnesota, United States
Medical Center of the Rockies (Loveland)
🇺🇸Loveland, Colorado, United States
Methodist Texsan Hospital
🇺🇸San Antonio, Texas, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
University Community Hospital
🇺🇸Tampa, Florida, United States
North Memorial Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
St. Joseph Hospital
🇺🇸Lexington, Kentucky, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Kaiser Foundation Hospitals
🇺🇸Honolulu, Hawaii, United States