XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

Coronary Artery Disease Clinical Trial

— XVU-AV DAPT  

Official title:

XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106534
• Other study ID #: 06-374C
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: July 2015

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia
• Vascular Disease
• Vascular Diseases

Intervention

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.
• 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.

Device:
• XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Abbott Medical Devices	Baim Institute for Clinical Research, Bristol-Myers Squibb, Daiichi Sankyo, Inc., Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Composite of All Death, MI and Stroke (Defined as MACE)		12-33 months post-stent
Primary	Incidence of ARC Definite or Probable ST		12-33 months post-stent
Primary	Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)		12-33 months post-stent
Secondary	MACE for ITT Population		12 through 30 months
Secondary	ST for ITT Population		12 through 30 months
Secondary	Major Bleeding for ITT Population		12 through 30 months
Secondary	MACE for Treatment Population		12 through 30 months and 12 through 33 months
Secondary	ST for Treatment Population		12 through 30 months and 12 through 33 months
Secondary	Major Bleeding for Treatment Population		12 through 30 months and 12 through 33 months