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)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Chronic Total Occlusion of Coronary Artery; Coronary Restenosis; Vascular Disease; Coronary Artery Stenosis
• Intervention / Treatment: Drug: placebo + aspirin; Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS); Drug: clopidogrel + aspirin OR prasugrel + aspirin

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
• Enrollment (Actual): 870
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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	Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS); XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.; 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 Names: Dual Antiplatelet Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Major Bleeding for Treatment Population	12 through 30 months and 12 through 33 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; Daiichi Sankyo, Inc.; Baim Institute for Clinical Research
• Investigators: Principal Investigator: James Hermiller, MD, Heart Center of Indianapolis; Principal Investigator: Mitch Krucoff, MD, Duke University

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimated): April 20, 2010

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stents; Angioplasty; drug eluting stents; Stent thrombosis; antiplatelet treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Ischemia; Coronary Stenosis; Coronary Restenosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; MTOR Inhibitors; Aspirin; Clopidogrel; Prasugrel Hydrochloride; Everolimus
• Other Study ID Numbers: 06-374C