XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/14/2017
Start Date:August 2009
End Date:July 2015

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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.

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.

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.
We found this trial at
144
sites
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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1045 North 30th Street
Billings, Montana 59101
406-255-8470
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Cincinnati, OH
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860 South Columbia Road
Grand Forks, North Dakota 58201
701-780-1750
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Grand Forks, ND
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albany, New York 12208
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Anderson, South Carolina 29621
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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620 13th Street
Augusta, Georgia 30901
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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4207 James Casey Street
Austin, Texas 78745
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Baltimore, Maryland
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Bangor, Maine 04401
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Beaver, Pennsylvania 15009
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Bellevue, Washington 98004
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Birmingham, Alabama 35235
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1 Boston Medical Center Place
Boston, Massachusetts 02118
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Brandon, Florida 33511
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1825 Eastchester Road
Bronx, New York 10461
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Buffalo, New York 14215
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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22 Saint Paul Drive
Chambersburg, Pennsylvania 17201
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Charlotte, North Carolina 28204
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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2525 Desales Avenue
Chattanooga, Tennessee 37404
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Clearwater, Florida 33756
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Columbia, South Carolina 29204
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Dearborn, Michigan 48123
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11600 West 2nd Place
Denver, Colorado 80204
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Detroit, Michigan 48236
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Doylestown, Pennsylvania 18901
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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630 River Street
Elyria, Ohio 44035
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Eugene, Oregon 97401
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Everett, Washington 98201
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Fairhope, Alabama 36532
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18101 Lorain Avenue
Fairview Park, Ohio 44126
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1201 Sam Perry Boulevard
Fredericksburg, Virginia 22401
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2333 Mowry Avenue
Fremont, California 94538
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743 Spring Street Northeast
Gainesville, Georgia 30501
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Gastonia, North Carolina 28054
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Hackensack, New Jersey 07601
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210 West Atlantic Avenue
Haddon Heights, New Jersey 08035
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Harrisburg, Pennsylvania 17110
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Hattiesburg, Mississippi 39401
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High Point, North Carolina 27261
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Hollywood, Florida 33021
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Houston, Texas 77030
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2900 1st Avenue
Huntington, West Virginia 25701
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1801 Senate Blvd
Indianapolis, Indiana 46202
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Indianapolis, Indiana 46237
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Indianapolis, Indiana 46250
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Jackson, Mississippi 39216
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Kansas City, Missouri 64111
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Lancaster, Pennsylvania 17603
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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1 Medical Center Drive
Lebanon, New Hampshire 03766
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Little Rock, Arkansas 72211
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Lombard, Illinois 60148
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10642 California State Route 2
Los Angeles, California 90017
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Lubbock, Texas 79416
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Marietta, Georgia 30106
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100 North Humphreys Boulevard
Memphis, Tennessee 38120
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Midwest City, Oklahoma 73110
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Minneapolis, Minnesota 55422
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4050 Coon Rapids Boulevard Northwest
Minneapolis, Minnesota 55433
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Nashville, Tennessee 37205
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1211 Medical Center Drive
Nashville, Tennessee 37205
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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North Kansas City, Missouri 64116
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40 Cross Street
Norwalk, Connecticut 06851
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NY, New York 10029
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Oklahoma City, Oklahoma 73112
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Paterson, New Jersey 07503
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Pensacola, Florida 32504
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515 Northeast Glen Oak Avenue
Peoria, Illinois 61603
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Petoskey, Michigan 49770
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Philadelphia, Pennsylvania
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Philadelphia, Pennsylvania
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4800 Friendship Ave
Pittsburgh, Pennsylvania 15224
(412) 578-5000
Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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Pontiac, Michigan 48341
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
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Raleigh, North Carolina
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