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Chronic Total Occlusion of Coronary ArteryPhase 4XVU-AV DAPTNCT01106534

XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

A Phase 4 study testing clopidogrel + aspirin OR prasugrel + aspirin and XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) in people with Chronic Total Occlusion of Coronary Artery and Vascular Disease, run by Abbott Medical Devices at 144 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
clopidogrel + aspirin OR prasugrel + aspirin and XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
870 participants
Where
144 sitesUnited States
Study dates
Aug 2009to Jul 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 12Show fewer
  • 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.

Trial locations and contacts

144 sites in 1 country.

144 sites in 1 country

United States144 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • St. Peters Hospital

    Albany, New York, 12208

  • Amarillo Heart Clinical Research Institute

    Amarillo, Texas, 79106

  • AnMed Health

    Anderson, South Carolina, 29621

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • University Hospital Augusta Cardiology Clinic

    Augusta, Georgia, 30901

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Capital Cadiovascular Specialists

    Austin, Texas, 78745

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • Tri-State Medical Group

    Beaver, Pennsylvania, 15009

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Billings Clinic Research Center

    Billings, Montana, 59107-7000

  • Birmingham Heart Clinic, PC

    Birmingham, Alabama, 35235

  • Boston Medical Center East

    Boston, Massachusetts, 02118

  • Brandon Regional Hospital

    Brandon, Florida, 33511

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Buffalo Heart group

    Buffalo, New York, 14203

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Franklin County Heart Center at Summit Cardiology

    Chambersburg, Pennsylvania, 17201

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Mid Carolina Cardiology

    Charlotte, North Carolina, 28204

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Memorial Health System

    Chattanooga, Tennessee, 37404

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Providence Hospital-SC

    Columbia, South Carolina, 29204

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • St. Anthony's Central Hospital

    Denver, Colorado, 80204

  • St John Hospital & Medical Center

    Detroit, Michigan, 48236

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Elkhart Midwest Cardiovascular Research & Education Foundation

    Elkhart, Indiana, 46514

  • North Ohio Research LTD, Elyria Regional Medical Center

    Elyria, Ohio, 44035

  • Englewood Hospital & Medical Center

    Englewood, New Jersey, 07631

  • Sacred Heart Medical Center

    Eugene, Oregon, 97401

  • Providence Everett Medical Center

    Everett, Washington, 98206

  • Thomas Hospital

    Fairhope, Alabama, 36532

  • Fairview Hospital

    Fairview Park, Ohio, 44126

  • Virginia Cardiovascular Consultants

    Fredericksburg, Virginia, 22401

  • California Cardiovascular Consultants

    Fremont, California, 94538

  • NE Georgia Medical Center

    Gainesville, Georgia, 30501

  • Gaston Memorial Hospital

    Gastonia, North Carolina, 28054

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601

  • CADV

    Haddon Heights, New Jersey, 08035

  • Harrisburg Hospital / Pinnacle Health

    Harrisburg, Pennsylvania, 17110

  • Southern Heart Center

    Hattiesburg, Mississippi, 39401

  • High Point Regional Health System

    High Point, North Carolina, 27262

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • The Methodist Hospital

    Houston, Texas, 77030

  • St Mary's Medical Hospital

    Huntington, West Virginia, 25701

  • The Care Group at Methodist

    Indianapolis, Indiana, 46202

  • St. Francis Hospital and Health Centers

    Indianapolis, Indiana, 46237

  • Indiana Heart Hospital

    Indianapolis, Indiana, 46250

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Lancaster Heart & Stroke Foundation

    Lancaster, Pennsylvania, 17603

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Dartmouth Hitchock Medical Center

    Lebanon, New Hampshire, 03756

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Midwest Heart Foundation

    Lombard, Illinois, 60148

  • FACT/ Los Angeles Cardiology

    Los Angeles, California, 90017

  • University of Southern California

    Los Angeles, California, 90033

  • Lubbock Heart Hospital

    Lubbock, Texas, 79416

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30060

  • West Clinic d/b/a Memphis Heart Clinic

    Memphis, Tennessee, 38120

  • Midwest Regional Medical Center

    Midwest City, Oklahoma, 73110

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • North Memorial Medical Center

    Minneapolis, Minnesota, 55422

  • Mercy Hospital

    Minneapolis, Minnesota, 55433

  • Centennial Heart Cardiovascular Consultants, LLC.

    Nashville, Tennessee, 37203

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt Vniversity Medical Center

    Nashville, Tennessee, 37205

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • St. Vincent's Medical Center

    Norwalk, Connecticut, 06851

  • Permian Research Foundation

    Odessa, Texas, 79761

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Integris Baptist Medical, Inc.

    Oklahoma City, Oklahoma, 73112

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Hospital

    Pensacola, Florida, 32504-8721

  • Heart Care Midwest (OSF/St Francis)

    Peoria, Illinois, 61603

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Hahnemann Hospital

    Philadelphia, Pennsylvania, 19102

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • St. Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • WakeMed Hospital

    Raleigh, North Carolina, 27610

  • Eisenhower Medical Center, Desert Cardiology Center

    Rancho Mirage, California, 92270

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Roanoke Memorial

    Roanoke, Virginia, 24014

  • Rochester Cardiopulmonary Group

    Rochester, New York, 14621

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Regional Cardiology Associates

    Sacramento, California, 95819

  • Michigan Cardio Vascular Institute at St. Mary's of MI

    Saginaw, Michigan, 48601

  • Covenant Medical Center, INC.

    Saginaw, Michigan, 48602

  • Lakeland Hospital St. Joseph

    Saint Joseph, Michigan, 49085

  • St. Paul Heart Clinic

    Saint Paul, Minnesota, 55102

  • Salinas Valley Memorial Healthcare System

    Salinas, California, 93901

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21804

  • Intermountain Medical Center

    Salt Lake City, Utah, 84103

  • South Texas Methodist Hospital

    San Antonio, Texas, 78229

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57104

  • Maine Cardiology Associates

    South Portland, Maine, 04106

  • St. John's Hospital / Prairie Education & Research Cooperative

    Springfield, Illinois, 62769

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • St. John's Research Institute, Inc., St. John's Hospital

    Springfield, Missouri, 65807

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stony Brook Hospital and Medical Center

    Stony Brook, New York, 11794

  • St. Joseph's Hospital Health Center

    Syracuse, New York, 13203

  • St. Joseph's Tacoma

    Tacoma, Washington, 98405

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Jack D. Weiler Hospital of Montefiore Medical Center

    The Bronx, New York, 10461

  • The Toledo Hospital-Jobst Vascular Center

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66604

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wisconsin Heart Hospital

    Wauwatosa, Wisconsin, 53226

  • Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center)

    Wellington, Florida, 33458

  • Galichia Heart Hospital

    Wichita, Kansas, 67220

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Holy Spirit Hospital

    Wormleysburg, Pennsylvania, 17043

  • Main Line Health Heart Center/The Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • York Hospital

    York, Pennsylvania, 17405

  • St. Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

  • Cardiology Associates of Southeastern Ohio, Inc

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.
Read the 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.

Being tested
placebo + aspirin, clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Keywords
drug eluting stents, Stents, Angioplasty, Stent thrombosis, antiplatelet treatment
Medical subject headings
Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebo + aspirinDrug

    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.

  • clopidogrel + aspirin OR prasugrel + aspirinDrug

    Also called Dual Antiplatelet Therapy

    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 (XIENCE V EECSS)Device

    XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.

Study groups in NCT01106534
Study groupRoleWhat they receive
12 month DAPT armPlacebo comparatorplacebo + aspirin
Receives: Drug: placebo + aspirin; Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
30 month DAPT armActive comparatorclopidogrel + aspirin OR prasugrel + aspirin
Receives: Drug: clopidogrel + aspirin OR prasugrel + aspirin; Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Composite of All Death, MI and Stroke (Defined as MACE)

    Measured: 12-33 months post-stent

  2. Incidence of ARC Definite or Probable ST

    Measured: 12-33 months post-stent

  3. Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)

    Measured: 12-33 months post-stent

Secondary outcomes (6)

  1. MACE for ITT Population

    Measured: 12 through 30 months

  2. ST for ITT Population

    Measured: 12 through 30 months

  3. Major Bleeding for ITT Population

    Measured: 12 through 30 months

  4. MACE for Treatment Population

    Measured: 12 through 30 months and 12 through 33 months

  5. ST for Treatment Population

    Measured: 12 through 30 months and 12 through 33 months

  6. Major Bleeding for Treatment Population

    Measured: 12 through 30 months and 12 through 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionFeb 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
870 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106534
Sponsor's protocol ID
06-374C
Acronym
XVU-AV DAPT
Status last verified
Oct 2023
First submitted
16 Apr 2010
Last updated
14 Nov 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing clopidogrel + aspirin OR prasugrel + aspirin and XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) in people with Chronic Total Occlusion of Coronary Artery and Vascular Disease, run by Abbott Medical Devices at 144 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Composite of All Death, MI and Stroke (Defined as MACE) (time frame: 12-33 months post-stent). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01106534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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