XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

NCT ID: NCT01106534

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 870 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

12 month DAPT arm

placebo + aspirin

Group Type: PLACEBO_COMPARATOR

placebo + aspirin

Intervention Type: DRUG

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.

XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

Intervention Type: DEVICE

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

30 month DAPT arm

clopidogrel + aspirin OR prasugrel + aspirin

Group Type: ACTIVE_COMPARATOR

clopidogrel + aspirin OR prasugrel + aspirin

Intervention Type: DRUG

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)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

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

Intervention Type: DEVICE

Other Intervention Names

Dual Antiplatelet Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baim Institute for Clinical Research

OTHER

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Hermiller, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center of Indianapolis

Mitch Krucoff, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Birmingham Heart Clinic, PC

Birmingham, Alabama, United States

Thomas Hospital

Fairhope, Alabama, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

California Cardiovascular Consultants

Fremont, California, United States

FACT/ Los Angeles Cardiology

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

Eisenhower Medical Center, Desert Cardiology Center

Rancho Mirage, California, United States

Regional Cardiology Associates

Sacramento, California, United States

Salinas Valley Memorial Healthcare System

Salinas, California, United States

Sansum Clinic

Santa Barbara, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

St. Anthony's Central Hospital

Denver, Colorado, United States

St. Vincent's Medical Center

Norwalk, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Brandon Regional Hospital

Brandon, Florida, United States

Morton Plant Hospital

Clearwater, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

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

Wellington, Florida, 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

NE Georgia Medical Center

Gainesville, Georgia, United States

WellStar Kennestone Hospital

Marietta, Georgia, United States

Midwest Heart Foundation

Lombard, Illinois, United States

Heart Care Midwest (OSF/St Francis)

Peoria, Illinois, United States

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

Springfield, Illinois, United States

Elkhart Midwest Cardiovascular Research & Education Foundation

Elkhart, Indiana, 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

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Galichia Heart Hospital

Wichita, Kansas, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Northeast Cardiology Associates

Bangor, Maine, United States

Maine Cardiology Associates

South Portland, Maine, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

St. Joseph Medical Center

Towson, Maryland, United States

Boston Medical Center East

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

St John Hospital & Medical Center

Detroit, Michigan, United States

Sparrow Hospital

Lansing, Michigan, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

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

Saginaw, Michigan, United States

Covenant Medical Center, INC.

Saginaw, Michigan, United States

Lakeland Hospital St. Joseph

Saint Joseph, Michigan, United States

St. Joseph Mercy Hospital

Ypsilanti, Michigan, United States

North Memorial Medical Center

Minneapolis, Minnesota, United States

Mercy Hospital

Minneapolis, Minnesota, United States

St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Southern Heart Center

Hattiesburg, Mississippi, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

North Kansas City Hospital

North Kansas City, Missouri, United States

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

Springfield, Missouri, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Billings Clinic Research Center

Billings, Montana, United States

Dartmouth Hitchock Medical Center

Lebanon, New Hampshire, United States

Englewood Hospital & Medical Center

Englewood, New Jersey, United States

Hackensack Medical Center

Hackensack, New Jersey, United States

CADV

Haddon Heights, New Jersey, United States

St. Joseph's Regional Medical Center

Paterson, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

St. Peters Hospital

Albany, New York, United States

Buffalo Heart group

Buffalo, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Rochester Cardiopulmonary Group

Rochester, New York, 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

Jack D. Weiler Hospital of Montefiore Medical Center

The Bronx, New York, 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

Duke University Medical Center

Durham, North Carolina, United States

Gaston Memorial Hospital

Gastonia, North Carolina, United States

High Point Regional Health System

High Point, North Carolina, United States

WakeMed Hospital

Raleigh, 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

Altru Health System

Grand Forks, North Dakota, United States

The Christ Hospital

Cincinnati, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

North Ohio Research LTD, Elyria Regional Medical Center

Elyria, Ohio, United States

Fairview Hospital

Fairview Park, Ohio, United States

The Toledo Hospital-Jobst Vascular Center

Toledo, Ohio, United States

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Cardiology Associates of Southeastern Ohio, Inc

Zanesville, Ohio, United States

Midwest Regional Medical Center

Midwest City, Oklahoma, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Integris Baptist Medical, Inc.

Oklahoma City, Oklahoma, United States

Hillcrest Medical Center

Tulsa, Oklahoma, United States

Sacred Heart Medical Center

Eugene, Oregon, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Tri-State Medical Group

Beaver, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Franklin County Heart Center at Summit Cardiology

Chambersburg, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

Harrisburg Hospital / Pinnacle Health

Harrisburg, Pennsylvania, United States

Lancaster Heart & Stroke Foundation

Lancaster, Pennsylvania, United States

Hahnemann Hospital

Philadelphia, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 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

The Miriam Hospital

Providence, Rhode Island, United States

AnMed Health

Anderson, South Carolina, United States

Providence Hospital-SC

Columbia, South Carolina, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Memorial Health System

Chattanooga, Tennessee, United States

West Clinic d/b/a Memphis Heart Clinic

Memphis, Tennessee, 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

Amarillo Heart Clinical Research Institute

Amarillo, Texas, United States

Capital Cadiovascular Specialists

Austin, Texas, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Lubbock Heart Hospital

Lubbock, Texas, United States

Permian Research Foundation

Odessa, Texas, United States

South Texas Methodist Hospital

San Antonio, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Cardiovascular Consultants

Fredericksburg, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Carilion Roanoke Memorial

Roanoke, Virginia, United States

Overlake Hospital Medical Center

Bellevue, Washington, United States

Providence Everett Medical Center

Everett, Washington, United States

St. Joseph's Tacoma

Tacoma, Washington, United States

St Mary's Medical Hospital

Huntington, West Virginia, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Wisconsin Heart Hospital

Wauwatosa, Wisconsin, United States

Countries

United States

Other Identifiers

06-374C

Identifier Type: -

Identifier Source: org_study_id