XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106534
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Baim Institute for Clinical Research
Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Abbott Vascular

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.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion of Coronary Artery Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Drug: placebo + aspirin Drug: clopidogrel + aspirin OR prasugrel + aspirin Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
Study Start Date : August 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 12 month DAPT arm
placebo + aspirin
Drug: placebo + 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 18 months of placebo treatment in addition to aspirin.
Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
Active Comparator: 30 month DAPT arm
clopidogrel + aspirin OR prasugrel + aspirin
Drug: clopidogrel + aspirin OR prasugrel + 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.
Other Name: Dual Antiplatelet Therapy
Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.

Primary Outcome Measures :
  1. Incidence of Composite of All Death, MI and Stroke (Defined as MACE) [ Time Frame: 12-33 months post-stent ]
  2. Incidence of ARC Definite or Probable ST [ Time Frame: 12-33 months post-stent ]
  3. Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) [ Time Frame: 12-33 months post-stent ]

Secondary Outcome Measures :
  1. MACE for ITT Population [ Time Frame: 12 through 30 months ]
  2. ST for ITT Population [ Time Frame: 12 through 30 months ]
  3. Major Bleeding for ITT Population [ Time Frame: 12 through 30 months ]
  4. MACE for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]
  5. ST for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]
  6. Major Bleeding for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106534

  Hide Study Locations
United States, Alabama
Birmingham Heart Clinic, PC
Birmingham, Alabama, United States, 35235
Thomas Hospital
Fairhope, Alabama, United States, 36532
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
California Cardiovascular Consultants
Fremont, California, United States, 94538
FACT/ Los Angeles Cardiology
Los Angeles, California, United States, 90017
University of Southern California
Los Angeles, California, United States, 90033
Eisenhower Medical Center, Desert Cardiology Center
Rancho Mirage, California, United States, 92270
Regional Cardiology Associates
Sacremento, California, United States, 95819
Salinas Valley Memorial Healthcare System
Salinas, California, United States, 93901
Sansum Clinic
Santa Barbara, California, United States, 93105
Torrance Memorial Medical Center
Torrance, California, United States, 90505
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
St. Anthony's Central Hospital
Denver, Colorado, United States, 80204
United States, Connecticut
St. Vincent's Medical Center
Norwalk,, Connecticut, United States, 06851
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Brandon Regional Hospital
Brandon, Florida, United States, 33511
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Sacred Heart Hospital
Pensacola, Florida, United States, 32504-8721
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)
Wellington, Florida, United States, 33458
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
University Hospital Augusta Cardiology Clinic
Augusta, Georgia, United States, 30901
NE Georgia Medical Center
Gainesville, Georgia, United States, 30501
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060
United States, Illinois
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
Heart Care Midwest (OSF/St Francis)
Peoria, Illinois, United States, 61603
St. John's Hospital / Prairie Education & Research Cooperative
Springfield, Illinois, United States, 62769
United States, Indiana
Elkhart Midwest Cardiovascular Research & Education Foundation
Elkhart, Indiana, United States, 46514
The Care Group at Methodist
Indianapolis, Indiana, United States, 46202
St. Francis Hospital and Health Centers
Indianapolis, Indiana, United States, 46237
Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
United States, Kansas
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66604
Galichia Heart Hospital
Wichita, Kansas, United States, 67220
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Maine
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
Maine Cardiology Associates
South Portland, Maine, United States, 04106
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21804
Washington Adventist Hospital
Tacoma Park, Maryland, United States, 20912
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston Medical Center East
Boston, Massachusetts, United States, 02118
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
St John Hospital & Medical Center
Detroit, Michigan, United States, 48236
Sparrow Hospital
Lansing,, Michigan, United States, 48912
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Michigan Cardio Vascular Institute at St. Mary's of MI
Saginaw, Michigan, United States, 48601
Covenant Medical Center, INC.
Saginaw, Michigan, United States, 48602
Lakeland Hospital St. Joseph
St. Joseph, Michigan, United States, 49085
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
North Memorial Medical Center
Minneapolis, Minnesota, United States, 55422
Mercy Hospital
Minneapolis, Minnesota, United States, 55433
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
United States, Mississippi
Southern Heart Center
Hattiesburg, Mississippi, United States, 39401
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
St. John's Research Institute, Inc., St. John's Hospital
Springfield, Missouri, United States, 65807
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic Research Center
Billings, Montana, United States, 59107-7000
United States, New Hampshire
Dartmouth Hitchock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Englewood Hospital & Medical Center
Englewood, New Jersey, United States, 07631
Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
Haddon Heights,, New Jersey, United States, 08035
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
St. Peters Hospital
Albany, New York, United States, 12208
Jack D. Weiler Hospital of Montefiore Medical Center
Bronx, New York, United States, 10461
Buffalo Heart group
Buffalo, New York, United States, 14203
Mount Sinai Medical Center
NY, New York, United States, 10029
Rochester Cardiopulmonary Group
Rochester, New York, United States, 14621
Stony Brook Hospital and Medical Center
Stony Brook, New York, United States, 11794
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Mid Carolina Cardiology
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
High Point Regional Health System
High Point, North Carolina, United States, 27262
WakeMed Hospital
Raleigh, North Carolina, United States, 27610
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Altru Health System
Grand Forks, North Dakota, United States, 58201
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
North Ohio Research LTD, Elyria Regional Medical Center
Elyria, Ohio, United States, 44035
Fairview Hospital
Fairview Park, Ohio, United States, 44126
The Toledo Hospital-Jobst Vascular Center
Toledo, Ohio, United States, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Cardiology Associates of Southeastern Ohio, Inc
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Midwest Regional Medical Center
Midwest City, Oklahoma, United States, 73110
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Integris Baptist Medical, Inc.
Oklahoma City, Oklahoma, United States, 73112
Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Sacred Heart Medical Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Tri-State Medical Group
Beaver, Pennsylvania, United States, 15009
Bryn Mawr Hospital
Bryn Mawr,, Pennsylvania, United States, 19010
Franklin County Heart Center at Summit Cardiology
Chambersburg, Pennsylvania, United States, 17201
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Harrisburg Hospital / Pinnacle Health
Harrisburg, Pennsylvania, United States, 17110
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, United States, 17603
Hahnemann Hospital
Philadelphia, Pennsylvania, United States, 19102
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Holy Spirit Hospital
Wormleysburg, Pennsylvania, United States, 17043
Main Line Health Heart Center/The Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
York Hospital
York, Pennsylvania, United States, 17405
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
AnMed Health
Anderson, South Carolina, United States, 29621
Providence Hospital-SC
Columbia, South Carolina, United States, 29204
United States, South Dakota
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Memorial Health System
Chattanooga, Tennessee, United States, 37404
West Clinic d/b/a Memphis Heart Clinic
Memphis, Tennessee, United States, 38120
Centennial Heart Cardiovascular Consultants, LLC.
Nashville, Tennessee, United States, 37203
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
Vanderbilt Vniversity Medical Center
Nashville, Tennessee, United States, 37205
United States, Texas
Amarillo Heart Clinical Research Institute
Amarillo, Texas, United States, 79106
Capital Cadiovascular Specialists
Austin, Texas, United States, 78745
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226
The Methodist Hospital
Houston, Texas, United States, 77030
Lubbock Heart Hospital
Lubbock, Texas, United States, 79416
Permian Research Foundation
Odessa, Texas, United States, 79761
South Texas Methodist Hospital
San Antonio, Texas, United States, 78229
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84103
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Virginia Cardiovascular Consultants
Fredericksburg, Virginia, United States, 22401
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Carilion Roanoke Memorial
Roanoke, Virginia, United States, 24014
United States, Washington
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
Providence Everett Medical Center
Everett, Washington, United States, 98206
St. Joseph's Tacoma
Tacoma, Washington, United States, 98405
United States, West Virginia
St Mary's Medical Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Wisconsin Heart Hospital
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Abbott Vascular
Baim Institute for Clinical Research
Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo, Inc.
Principal Investigator: James Hermiller, MD Heart Center of Indianapolis
Principal Investigator: Mitch Krucoff, MD Duke University

Responsible Party: Abbott Vascular Identifier: NCT01106534     History of Changes
Other Study ID Numbers: 06-374C
First Posted: April 20, 2010    Key Record Dates
Results First Posted: June 28, 2016
Last Update Posted: June 28, 2016
Last Verified: May 2016

Keywords provided by Abbott Vascular:
drug eluting stents
Stent thrombosis
antiplatelet treatment

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Pathologic Processes
Prasugrel Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors