Clinical trial NCT01106534: XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Official title: XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Total Occlusion of Coronary Artery
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: drug eluting stents
Stents
Angioplasty
Stent thrombosis
antiplatelet treatment
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Baim Institute for Clinical Research
name: Bristol-Myers Squibb
name: Eli Lilly and Company
name: Daiichi Sankyo
First posted: 2010-04-20
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are

* To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
* To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Detailed description: This prospective, multi-center, randomized, double-blind AV-DAPT study cohort is designed to collect data to support the FDA DAPT initiative. The protocol for AV-DAPT cohort is designed according to the HCRI-DAPT (NCT00977938) study protocol, Study IDE # G080186.

A total 8040 patients (5034 in initial enrollment phase and additional \~3000 patients in the second enrollment phase) enrolled in the XIENCE V USA (NCT00676520) had completed Phase I and were evaluated at 1 year.

These patients were transferred to the following cohorts in Phase II and followed-up for 1-5 years:

The long-term follow-up cohort of phase II (NCT01120379) consisted of 5020 patients from the first enrollment phase who were not transferred to the HCRI- DAPT study and remained in the study beyond 1 year.

Patients from the additional 3000 treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.

The remaining patients from the additional 3000 patients who did not participate in AV-DAPT cohort will be followed for the first year only. A study completion form will be filled out and the patients will not be followed beyond their 1 year visit.

The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients who are enrolled into the XIENCE V USA Study Phase I
* The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

* The inability to obtain an informed consent is an exclusion criterion.

Patients must meet the following criteria to be eligible for randomization in the study:

* Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".
* Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".
* Patient completes 1 year visit within ± 30 days window.

Patients will be excluded from randomization if any of the following criteria are met:

* Pregnant women.
* Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.
* PCI or cardiac surgery between 6 weeks post index procedure and randomization.
* Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
* Current medical condition with a life expectancy of less than 3 years.
* Patients on warfarin or similar anticoagulant therapy.

Primary outcomes:
measure: Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
timeFrame: 12-33 months post-stent
measure: Incidence of ARC Definite or Probable ST
timeFrame: 12-33 months post-stent
measure: Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
timeFrame: 12-33 months post-stent
Secondary outcomes:
measure: MACE for ITT Population
timeFrame: 12 through 30 months
measure: ST for ITT Population
timeFrame: 12 through 30 months
measure: Major Bleeding for ITT Population
timeFrame: 12 through 30 months
measure: MACE for Treatment Population
timeFrame: 12 through 30 months and 12 through 33 months
measure: ST for Treatment Population
timeFrame: 12 through 30 months and 12 through 33 months
measure: Major Bleeding for Treatment Population
timeFrame: 12 through 30 months and 12 through 33 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Heart Clinic, PC
state: Alabama
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Fremont
country: United States
facility: California Cardiovascular Consultants
state: California
city: Los Angeles
country: United States
facility: FACT/ Los Angeles Cardiology
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center, Desert Cardiology Center
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Denver
country: United States
facility: St. Anthony's Central Hospital
state: Colorado
city: Norwalk
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Augusta
country: United States
facility: University Hospital Augusta Cardiology Clinic
state: Georgia
city: Gainesville
country: United States
facility: NE Georgia Medical Center
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Peoria
country: United States
facility: Heart Care Midwest (OSF/St Francis)
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital / Prairie Education & Research Cooperative
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Midwest Cardiovascular Research & Education Foundation
state: Indiana
city: Indianapolis
country: United States
facility: The Care Group at Methodist
state: Indiana
city: Indianapolis
country: United States
facility: St. Francis Hospital and Health Centers
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Wichita
country: United States
facility: Galichia Heart Hospital
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: South Portland
country: United States
facility: Maine Cardiology Associates
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center East
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: St John Hospital & Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardio Vascular Institute at St. Mary's of MI
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center, INC.
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Hospital St. Joseph
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Minneapolis
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Mercy Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
city: Hattiesburg
country: United States
facility: Southern Heart Center
state: Mississippi
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Springfield
country: United States
facility: St. John's Research Institute, Inc., St. John's Hospital
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Center
state: Montana
city: Lebanon
country: United States
facility: Dartmouth Hitchock Medical Center
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital & Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Haddon Heights
country: United States
facility: CADV
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albany
country: United States
facility: St. Peters Hospital
state: New York
city: Bronx
country: United States
facility: Jack D. Weiler Hospital of Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo Heart group
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester Cardiopulmonary Group
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Hospital and Medical Center
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Memorial Hospital
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Health System
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research LTD, Elyria Regional Medical Center
state: Ohio
city: Fairview Park
country: United States
facility: Fairview Hospital
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital-Jobst Vascular Center
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Cardiology Associates of Southeastern Ohio, Inc
state: Ohio
city: Midwest City
country: United States
facility: Midwest Regional Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Baptist Medical, Inc.
state: Oklahoma
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Eugene
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Beaver
country: United States
facility: Tri-State Medical Group
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Chambersburg
country: United States
facility: Franklin County Heart Center at Summit Cardiology
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Hospital / Pinnacle Health
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Heart & Stroke Foundation
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Heart Center/The Lankenau Hospital
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Columbia
country: United States
facility: Providence Hospital-SC
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: Memorial Health System
state: Tennessee
city: Memphis
country: United States
facility: West Clinic d/b/a Memphis Heart Clinic
state: Tennessee
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants, LLC.
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Vniversity Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Capital Cadiovascular Specialists
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Lubbock
country: United States
facility: Lubbock Heart Hospital
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: San Antonio
country: United States
facility: South Texas Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fredericksburg
country: United States
facility: Virginia Cardiovascular Consultants
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Tacoma
country: United States
facility: St. Joseph's Tacoma
state: Washington
city: Huntington
country: United States
facility: St Mary's Medical Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Wauwatosa
country: United States
facility: Wisconsin Heart Hospital
state: Wisconsin
Study officials:
affiliation: Heart Center of Indianapolis
name: James Hermiller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Mitch Krucoff, MD
role: PRINCIPAL_INVESTIGATOR
References: