XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

Phase 4

Completed

Conditions: Chronic Total Occlusion of Coronary Artery
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis

Interventions: Drug: placebo + aspirin
Drug: clopidogrel + aspirin OR prasugrel + aspirin
Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

Registration Number: NCT01106534

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 870

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 month DAPT arm	placebo + aspirin	placebo + aspirin
12 month DAPT arm	XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)	placebo + aspirin
30 month DAPT arm	clopidogrel + aspirin OR prasugrel + aspirin	clopidogrel + aspirin OR prasugrel + aspirin
30 month DAPT arm	XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)	clopidogrel + aspirin OR prasugrel + aspirin

Primary Outcome Measures

Name	Time	Method
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)	12-33 months post-stent
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

Secondary Outcome Measures

Name	Time	Method
ST for ITT Population	12 through 30 months
MACE 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

Trial Locations

Locations (144): Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
The Care Group at Methodist
🇺🇸
Indianapolis, Indiana, United States
St. Francis Hospital and Health Centers
🇺🇸
Indianapolis, Indiana, United States
Indiana Heart Hospital
🇺🇸
Indianapolis, Indiana, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
University of Cincinnati Medical Center
🇺🇸
Cincinnati, Ohio, United States
North Memorial Medical Center
🇺🇸
Minneapolis, Minnesota, United States
Mercy Hospital
🇺🇸
Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
South Texas Methodist Hospital
🇺🇸
San Antonio, Texas, United States
St. John's Research Institute, Inc., St. John's Hospital
🇺🇸
Springfield, Missouri, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Scottsdale Healthcare
🇺🇸
Scottsdale, Arizona, United States
Thomas Hospital
🇺🇸
Fairhope, Alabama, United States
Jackson Heart Clinic
🇺🇸
Jackson, Mississippi, United States
Billings Clinic Research Center
🇺🇸
Billings, Montana, United States
Morton Plant Hospital
🇺🇸
Clearwater, Florida, United States
St. Joseph's Regional Medical Center
🇺🇸
Paterson, New Jersey, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Rochester Cardiopulmonary Group
🇺🇸
Rochester, New York, United States
FACT/ Los Angeles Cardiology
🇺🇸
Los Angeles, California, United States
North Kansas City Hospital
🇺🇸
North Kansas City, Missouri, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
The Toledo Hospital-Jobst Vascular Center
🇺🇸
Toledo, Ohio, United States
Sacred Heart Medical Center
🇺🇸
Eugene, Oregon, United States
Torrance Memorial Medical Center
🇺🇸
Torrance, California, United States
Altru Health System
🇺🇸
Grand Forks, North Dakota, United States
Saint Joseph's Hospital of Atlanta
🇺🇸
Atlanta, Georgia, United States
Fairview Hospital
🇺🇸
Fairview Park, Ohio, United States
Hillcrest Medical Center
🇺🇸
Tulsa, Oklahoma, United States
Elkhart Midwest Cardiovascular Research & Education Foundation
🇺🇸
Elkhart, Indiana, United States
Stony Brook Hospital and Medical Center
🇺🇸
Stony Brook, New York, United States
Hahnemann Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Buffalo Heart group
🇺🇸
Buffalo, New York, United States
St. Vincent Mercy Medical Center
🇺🇸
Toledo, Ohio, United States
Midwest Regional Medical Center
🇺🇸
Midwest City, Oklahoma, United States
Dartmouth Hitchock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Englewood Hospital & Medical Center
🇺🇸
Englewood, New Jersey, United States
Gaston Memorial Hospital
🇺🇸
Gastonia, North Carolina, United States
Cardiology Associates of Southeastern Ohio, Inc
🇺🇸
Zanesville, Ohio, United States
Bryn Mawr Hospital
🇺🇸
Bryn Mawr, Pennsylvania, United States
Doylestown Hospital
🇺🇸
Doylestown, Pennsylvania, United States
Virginia Cardiovascular Consultants
🇺🇸
Fredericksburg, Virginia, United States
West Clinic d/b/a Memphis Heart Clinic
🇺🇸
Memphis, Tennessee, United States
Franklin County Heart Center at Summit Cardiology
🇺🇸
Chambersburg, Pennsylvania, United States
Wisconsin Heart Hospital
🇺🇸
Wauwatosa, Wisconsin, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
St Mary's Medical Hospital
🇺🇸
Huntington, West Virginia, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
Overlake Hospital Medical Center
🇺🇸
Bellevue, Washington, United States
Main Line Health Heart Center/The Lankenau Hospital
🇺🇸
Wynnewood, Pennsylvania, United States
The Western Pennsylvania Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Holy Spirit Hospital
🇺🇸
Wormleysburg, Pennsylvania, United States
Lubbock Heart Hospital
🇺🇸
Lubbock, Texas, United States
Carilion Roanoke Memorial
🇺🇸
Roanoke, Virginia, United States
The Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Permian Research Foundation
🇺🇸
Odessa, Texas, United States
AnMed Health
🇺🇸
Anderson, South Carolina, United States
Cotton O'Neil Clinical Research Center
🇺🇸
Topeka, Kansas, United States
Galichia Heart Hospital
🇺🇸
Wichita, Kansas, United States
Baystate Medical Center
🇺🇸
Springfield, Massachusetts, United States
St. Thomas Hospital
🇺🇸
Nashville, Tennessee, United States
Centennial Heart Cardiovascular Consultants, LLC.
🇺🇸
Nashville, Tennessee, United States
Vanderbilt Vniversity Medical Center
🇺🇸
Nashville, Tennessee, United States
Integris Baptist Medical, Inc.
🇺🇸
Oklahoma City, Oklahoma, United States
The University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
St John Hospital & Medical Center
🇺🇸
Detroit, Michigan, United States
St. Vincent's Medical Center
🇺🇸
Norwalk, Connecticut, United States
Birmingham Heart Clinic, PC
🇺🇸
Birmingham, Alabama, United States
Barnes Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
The Medical Center of Aurora
🇺🇸
Aurora, Colorado, United States
Aurora St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Sparrow Hospital
🇺🇸
Lansing, Michigan, United States
Mid Carolina Cardiology
🇺🇸
Charlotte, North Carolina, United States
High Point Regional Health System
🇺🇸
High Point, North Carolina, United States
WakeMed Hospital
🇺🇸
Raleigh, North Carolina, United States
St. Peters Hospital
🇺🇸
Albany, New York, United States
California Cardiovascular Consultants
🇺🇸
Fremont, California, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Salinas Valley Memorial Healthcare System
🇺🇸
Salinas, California, United States
Sansum Clinic
🇺🇸
Santa Barbara, California, United States
St. Anthony's Central Hospital
🇺🇸
Denver, Colorado, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Brandon Regional Hospital
🇺🇸
Brandon, Florida, United States
Memorial Regional Hospital
🇺🇸
Hollywood, Florida, United States
Sacred Heart Hospital
🇺🇸
Pensacola, Florida, United States
Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)
🇺🇸
Wellington, Florida, United States
University Hospital Augusta Cardiology Clinic
🇺🇸
Augusta, Georgia, United States
NE Georgia Medical Center
🇺🇸
Gainesville, Georgia, United States
WellStar Kennestone Hospital
🇺🇸
Marietta, Georgia, United States
Midwest Heart Foundation
🇺🇸
Lombard, Illinois, United States
St. John's Hospital / Prairie Education & Research Cooperative
🇺🇸
Springfield, Illinois, United States
Heart Care Midwest (OSF/St Francis)
🇺🇸
Peoria, Illinois, United States
Maine Cardiology Associates
🇺🇸
South Portland, Maine, United States
Northeast Cardiology Associates
🇺🇸
Bangor, Maine, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Peninsula Regional Medical Center
🇺🇸
Salisbury, Maryland, United States
Lahey Clinic
🇺🇸
Burlington, Massachusetts, United States
St. Joseph Medical Center
🇺🇸
Towson, Maryland, United States
UMass Memorial Medical Center
🇺🇸
Worcester, Massachusetts, United States
Boston Medical Center East
🇺🇸
Boston, Massachusetts, United States
Oakwood Hospital and Medical Center
🇺🇸
Dearborn, Michigan, United States
Michigan Cardio Vascular Institute at St. Mary's of MI
🇺🇸
Saginaw, Michigan, United States
Northern Michigan Hospital
🇺🇸
Petoskey, Michigan, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
St. Joseph Mercy Oakland Hospital
🇺🇸
Pontiac, Michigan, United States
Covenant Medical Center, INC.
🇺🇸
Saginaw, Michigan, United States
St. Joseph Mercy Hospital
🇺🇸
Ypsilanti, Michigan, United States
Lakeland Hospital St. Joseph
🇺🇸
Saint Joseph, Michigan, United States
St. Paul Heart Clinic
🇺🇸
Saint Paul, Minnesota, United States
Southern Heart Center
🇺🇸
Hattiesburg, Mississippi, United States
St. Joseph's Hospital Health Center
🇺🇸
Syracuse, New York, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
Tri-State Medical Group
🇺🇸
Beaver, Pennsylvania, United States
Lancaster Heart & Stroke Foundation
🇺🇸
Lancaster, Pennsylvania, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Providence Hospital-SC
🇺🇸
Columbia, South Carolina, United States
Amarillo Heart Clinical Research Institute
🇺🇸
Amarillo, Texas, United States
Baylor Heart and Vascular Hospital
🇺🇸
Dallas, Texas, United States
Sarasota Memorial Hospital
🇺🇸
Sarasota, Florida, United States
Intermountain Medical Center
🇺🇸
Salt Lake City, Utah, United States
Eisenhower Medical Center, Desert Cardiology Center
🇺🇸
Rancho Mirage, California, United States
North Ohio Research LTD, Elyria Regional Medical Center
🇺🇸
Elyria, Ohio, United States
Memorial Health System
🇺🇸
Chattanooga, Tennessee, United States
Providence Everett Medical Center
🇺🇸
Everett, Washington, United States
St. Joseph's Tacoma
🇺🇸
Tacoma, Washington, United States
Hackensack Medical Center
🇺🇸
Hackensack, New Jersey, United States
CADV
🇺🇸
Haddon Heights, New Jersey, United States
Regional Cardiology Associates
🇺🇸
Sacramento, California, United States
St. Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
Forsyth Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Wake Forest University Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Washington Adventist Hospital
🇺🇸
Takoma Park, Maryland, United States
Jack D. Weiler Hospital of Montefiore Medical Center
🇺🇸
Bronx, New York, United States
Capital Cadiovascular Specialists
🇺🇸
Austin, Texas, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Sanford USD Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Harrisburg Hospital / Pinnacle Health
🇺🇸
Harrisburg, Pennsylvania, United States