XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
XVU-AV DAPT
XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
1 other identifier
interventional
870
1 country
144
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2009
Longer than P75 for phase_4
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
June 28, 2016
CompletedNovember 14, 2023
October 1, 2023
5.5 years
April 16, 2010
July 31, 2015
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
12-33 months post-stent
Incidence of ARC Definite or Probable ST
12-33 months post-stent
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
12-33 months post-stent
Secondary Outcomes (6)
MACE for ITT Population
12 through 30 months
ST for ITT Population
12 through 30 months
Major Bleeding for ITT Population
12 through 30 months
MACE for Treatment Population
12 through 30 months and 12 through 33 months
ST for Treatment Population
12 through 30 months and 12 through 33 months
- +1 more secondary outcomes
Study Arms (2)
12 month DAPT arm
PLACEBO COMPARATORplacebo + aspirin
30 month DAPT arm
ACTIVE COMPARATORclopidogrel + aspirin OR prasugrel + aspirin
Interventions
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients must meet the following criteria to be eligible for randomization in the study:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Baim Institute for Clinical Researchcollaborator
- Bristol-Myers Squibbcollaborator
- Eli Lilly and Companycollaborator
- Daiichi Sankyocollaborator
Study Sites (144)
Birmingham Heart Clinic, PC
Birmingham, Alabama, 35235, United States
Thomas Hospital
Fairhope, Alabama, 36532, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85260, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
California Cardiovascular Consultants
Fremont, California, 94538, United States
FACT/ Los Angeles Cardiology
Los Angeles, California, 90017, United States
University of Southern California
Los Angeles, California, 90033, United States
Eisenhower Medical Center, Desert Cardiology Center
Rancho Mirage, California, 92270, United States
Regional Cardiology Associates
Sacramento, California, 95819, United States
Salinas Valley Memorial Healthcare System
Salinas, California, 93901, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
St. Anthony's Central Hospital
Denver, Colorado, 80204, United States
St. Vincent's Medical Center
Norwalk, Connecticut, 06851, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Brandon Regional Hospital
Brandon, Florida, 33511, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Sacred Heart Hospital
Pensacola, Florida, 32504-8721, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)
Wellington, Florida, 33458, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
University Hospital Augusta Cardiology Clinic
Augusta, Georgia, 30901, United States
NE Georgia Medical Center
Gainesville, Georgia, 30501, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
Midwest Heart Foundation
Lombard, Illinois, 60148, United States
Heart Care Midwest (OSF/St Francis)
Peoria, Illinois, 61603, United States
St. John's Hospital / Prairie Education & Research Cooperative
Springfield, Illinois, 62769, United States
Elkhart Midwest Cardiovascular Research & Education Foundation
Elkhart, Indiana, 46514, United States
The Care Group at Methodist
Indianapolis, Indiana, 46202, United States
St. Francis Hospital and Health Centers
Indianapolis, Indiana, 46237, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66604, United States
Galichia Heart Hospital
Wichita, Kansas, 67220, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Northeast Cardiology Associates
Bangor, Maine, 04401, United States
Maine Cardiology Associates
South Portland, Maine, 04106, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21804, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Boston Medical Center East
Boston, Massachusetts, 02118, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
St John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Michigan Cardio Vascular Institute at St. Mary's of MI
Saginaw, Michigan, 48601, United States
Covenant Medical Center, INC.
Saginaw, Michigan, 48602, United States
Lakeland Hospital St. Joseph
Saint Joseph, Michigan, 49085, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
North Memorial Medical Center
Minneapolis, Minnesota, 55422, United States
Mercy Hospital
Minneapolis, Minnesota, 55433, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102, United States
Southern Heart Center
Hattiesburg, Mississippi, 39401, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
St. John's Research Institute, Inc., St. John's Hospital
Springfield, Missouri, 65807, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Billings Clinic Research Center
Billings, Montana, 59107-7000, United States
Dartmouth Hitchock Medical Center
Lebanon, New Hampshire, 03756, United States
Englewood Hospital & Medical Center
Englewood, New Jersey, 07631, United States
Hackensack Medical Center
Hackensack, New Jersey, 07601, United States
CADV
Haddon Heights, New Jersey, 08035, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
St. Peters Hospital
Albany, New York, 12208, United States
Buffalo Heart group
Buffalo, New York, 14203, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Rochester Cardiopulmonary Group
Rochester, New York, 14621, United States
Stony Brook Hospital and Medical Center
Stony Brook, New York, 11794, United States
St. Joseph's Hospital Health Center
Syracuse, New York, 13203, United States
Jack D. Weiler Hospital of Montefiore Medical Center
The Bronx, New York, 10461, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Mid Carolina Cardiology
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
High Point Regional Health System
High Point, North Carolina, 27262, United States
WakeMed Hospital
Raleigh, North Carolina, 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Altru Health System
Grand Forks, North Dakota, 58201, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
North Ohio Research LTD, Elyria Regional Medical Center
Elyria, Ohio, 44035, United States
Fairview Hospital
Fairview Park, Ohio, 44126, United States
The Toledo Hospital-Jobst Vascular Center
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Cardiology Associates of Southeastern Ohio, Inc
Zanesville, Ohio, 43701, United States
Midwest Regional Medical Center
Midwest City, Oklahoma, 73110, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Integris Baptist Medical, Inc.
Oklahoma City, Oklahoma, 73112, United States
Hillcrest Medical Center
Tulsa, Oklahoma, 74104, United States
Sacred Heart Medical Center
Eugene, Oregon, 97401, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Tri-State Medical Group
Beaver, Pennsylvania, 15009, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Franklin County Heart Center at Summit Cardiology
Chambersburg, Pennsylvania, 17201, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Harrisburg Hospital / Pinnacle Health
Harrisburg, Pennsylvania, 17110, United States
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, 17603, United States
Hahnemann Hospital
Philadelphia, Pennsylvania, 19102, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Holy Spirit Hospital
Wormleysburg, Pennsylvania, 17043, United States
Main Line Health Heart Center/The Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
York Hospital
York, Pennsylvania, 17405, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Providence Hospital-SC
Columbia, South Carolina, 29204, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104, United States
Memorial Health System
Chattanooga, Tennessee, 37404, United States
West Clinic d/b/a Memphis Heart Clinic
Memphis, Tennessee, 38120, United States
Centennial Heart Cardiovascular Consultants, LLC.
Nashville, Tennessee, 37203, United States
St. Thomas Hospital
Nashville, Tennessee, 37205, United States
Vanderbilt Vniversity Medical Center
Nashville, Tennessee, 37205, United States
Amarillo Heart Clinical Research Institute
Amarillo, Texas, 79106, United States
Capital Cadiovascular Specialists
Austin, Texas, 78745, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Lubbock Heart Hospital
Lubbock, Texas, 79416, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
South Texas Methodist Hospital
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Salt Lake City, Utah, 84103, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Cardiovascular Consultants
Fredericksburg, Virginia, 22401, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial
Roanoke, Virginia, 24014, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Providence Everett Medical Center
Everett, Washington, 98206, United States
St. Joseph's Tacoma
Tacoma, Washington, 98405, United States
St Mary's Medical Hospital
Huntington, West Virginia, 25701, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Wisconsin Heart Hospital
Wauwatosa, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The participants enrolled in this study will be followed by Abbott Vacular 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 outcomes.
Results Point of Contact
- Title
- David R Rutledge
- Organization
- Abbott Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
James Hermiller, MD
Heart Center of Indianapolis
- PRINCIPAL INVESTIGATOR
Mitch Krucoff, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2010
First Posted
April 20, 2010
Study Start
August 1, 2009
Primary Completion
February 1, 2015
Study Completion
July 1, 2015
Last Updated
November 14, 2023
Results First Posted
June 28, 2016
Record last verified: 2023-10