XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)
This study is ongoing, but not recruiting participants.
Sponsor:
Abbott Vascular
Collaborators:
Harvard Clinical Research Institute
Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01106534
First received: April 16, 2010
Last updated: September 17, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Coronary Occlusion Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis |
Drug: Thienopyridine (clopidogrel or prasugrel) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT) |
Resource links provided by NLM:
Further study details as provided by Abbott Vascular:
Primary Outcome Measures:
- Incidence of composite of all death, MI and stroke (defined as MACCE) [ Time Frame: 12-33 months post-stent ] [ Designated as safety issue: Yes ]
- Incidence of ARC definite or probable ST [ Time Frame: 12-33 months post-stent ] [ Designated as safety issue: Yes ]
- Major bleeding (GUSTO classification, severe and moderate bleeding combined) [ Time Frame: 12-33 months post-stent ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- MACCE for ITT population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
- ST for ITT population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
- Major bleed for ITT population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
- MACCE for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
- ST for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
- Major bleed for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 870 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 12m DAPT arm
placebo for clopidogrel + aspirin OR placebo for prasugrel + aspirin
|
Drug: Thienopyridine (clopidogrel or prasugrel)
Compare 12 and 30 months of DAPT treatment in patients undergoing PCI with stent placement
|
|
Active Comparator: 30 month DAPT arm
clopidogrel + aspirin OR prasugrel + aspirin
|
Drug: Thienopyridine (clopidogrel or prasugrel)
Compare 12 and 30 months of DAPT treatment in patients undergoing PCI with stent placement
|
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 study protocol, Study IDE # G080186. Patients from the additional 3,000 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 cohort. Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized to 18 months of active treatment with thienopyridines or placebo 12 months after index procedure. 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 3,000 patients who do 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106534
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| United States, Alabama | |
| Birmingham Heart Clinic, PC | |
| Birmingham, Alabama, United States, 35235 | |
| Thomas Hospital | |
| Fairhope, Alabama, United States, 36532 | |
| United States, Arizona | |
| Scottsdale Healthcare | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, Arkansas | |
| Arkansas Heart Hospital | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| California Cardiovascular Consultants | |
| Fremont, California, United States, 94538 | |
| FACT/ Los Angeles Cardiology | |
| Los Angeles, California, United States, 90017 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Eisenhower Medical Center, Desert Cardiology Center | |
| Rancho Mirage, California, United States, 92270 | |
| Regional Cardiology Associates | |
| Sacremento, California, United States, 95819 | |
| Salinas Valley Memorial Healthcare System | |
| Salinas, California, United States, 93901 | |
| Sansum Clinic | |
| Santa Barbara, California, United States, 93105 | |
| Torrance Memorial Medical Center | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| The Medical Center of Aurora | |
| Aurora, Colorado, United States, 80012 | |
| St. Anthony's Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| United States, Connecticut | |
| St. Vincent's Medical Center | |
| Norwalk,, Connecticut, United States, 06851 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Brandon Regional Hospital | |
| Brandon, Florida, United States, 33511 | |
| Morton Plant Hospital | |
| Clearwater, Florida, United States, 33756 | |
| Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Sacred Heart Hospital | |
| Pensacola, Florida, United States, 32504-8721 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34239 | |
| Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center) | |
| Wellington, Florida, United States, 33458 | |
| United States, Georgia | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| University Hospital Augusta Cardiology Clinic | |
| Augusta, Georgia, United States, 30901 | |
| NE Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| WellStar Kennestone Hospital | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Midwest Heart Foundation | |
| Lombard, Illinois, United States, 60148 | |
| Heart Care Midwest (OSF/St Francis) | |
| Peoria, Illinois, United States, 61603 | |
| St. John's Hospital / Prairie Education & Research Cooperative | |
| Springfield, Illinois, United States, 62769 | |
| United States, Indiana | |
| Elkhart Midwest Cardiovascular Research & Education Foundation | |
| Elkhart, Indiana, United States, 46514 | |
| St. Francis Hospital and Health Centers | |
| Indianapolis, Indiana, United States, 46237 | |
| Indiana Heart Hospital | |
| Indianapolis, Indiana, United States, 46250 | |
| The Care Group at Methodist | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Cotton O'Neil Clinical Research Center | |
| Topeka, Kansas, United States, 66604 | |
| Galichia Heart Hospital | |
| Wichita, Kansas, United States, 67220 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Maine | |
| Northeast Cardiology Associates | |
| Bangor, Maine, United States, 04401 | |
| Maine Cardiology Associates | |
| South Portland, Maine, United States, 04106 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| Union Memorial Hospital | |
| Baltimore, Maryland, United States, 21218 | |
| Peninsula Regional Medical Center | |
| Salisbury, Maryland, United States, 21804 | |
| Washington Adventist Hospital | |
| Tacoma Park, Maryland, United States, 20912 | |
| St. Joseph Medical Center | |
| Towson, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| Boston Medical Center East | |
| Boston, Massachusetts, United States, 02118 | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| UMass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48124 | |
| St John Hospital & Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| Sparrow Hospital | |
| Lansing,, Michigan, United States, 48912 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| St. Joseph Mercy Oakland Hospital | |
| Pontiac, Michigan, United States, 48341 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| Covenant Medical Center, INC. | |
| Saginaw, Michigan, United States, 48602 | |
| Michigan Cardio Vascular Institute at St. Mary's of MI | |
| Saginaw, Michigan, United States, 48601 | |
| Lakeland Hospital St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| St. Joseph Mercy Hospital | |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, Minnesota | |
| North Memorial Medical Center | |
| Minneapolis, Minnesota, United States, 55422 | |
| Mercy Hospital | |
| Minneapolis, Minnesota, United States, 55433 | |
| St. Paul Heart Clinic | |
| St. Paul, Minnesota, United States, 55102 | |
| United States, Mississippi | |
| Southern Heart Center | |
| Hattiesburg, Mississippi, United States, 39401 | |
| Jackson Heart Clinic | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| St. Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| North Kansas City Hospital | |
| North Kansas City, Missouri, United States, 64116 | |
| St. John's Research Institute, Inc., St. John's Hospital | |
| Springfield, Missouri, United States, 65807 | |
| Barnes Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Billings Clinic Research Center | |
| Billings, Montana, United States, 59107-7000 | |
| United States, New Hampshire | |
| Dartmouth Hitchock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Englewood Hospital & Medical Center | |
| Englewood, New Jersey, United States, 07631 | |
| Hackensack Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| CADV | |
| Haddon Heights,, New Jersey, United States, 08035 | |
| St. Joseph's Regional Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| The Valley Hospital | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| St. Peters Hospital | |
| Albany, New York, United States, 12208 | |
| Jack D. Weiler Hospital of Montefiore Medical Center | |
| Bronx, New York, United States, 10461 | |
| Buffalo Heart group | |
| Buffalo, New York, United States, 14203 | |
| Mount Sinai Medical Center | |
| NY, New York, United States, 10029 | |
| Rochester Cardiopulmonary Group | |
| Rochester, New York, United States, 14621 | |
| Stony Brook Hospital and Medical Center | |
| Stony Brook, New York, United States, 11794 | |
| St. Joseph's Hospital Health Center | |
| Syracuse, New York, United States, 13203 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Mid Carolina Cardiology | |
| Charlotte, North Carolina, United States, 28204 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Gaston Memorial Hospital | |
| Gastonia, North Carolina, United States, 28054 | |
| High Point Regional Health System | |
| High Point, North Carolina, United States, 27262 | |
| WakeMed Hospital | |
| Raleigh, North Carolina, United States, 27610 | |
| Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, North Dakota | |
| Altru Health System | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| The Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| North Ohio Research LTD, Elyria Regional Medical Center | |
| Elyria, Ohio, United States, 44035 | |
| Fairview Hospital | |
| Fairview Park, Ohio, United States, 44126 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| The Toledo Hospital-Jobst Vascular Center | |
| Toledo, Ohio, United States, 43606 | |
| Cardiology Associates of Southeastern Ohio, Inc | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| Midwest Regional Medical Center | |
| Midwest City, Oklahoma, United States, 73110 | |
| Integris Baptist Medical, Inc. | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| The University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Hillcrest Medical Center | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Sacred Heart Medical Center | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Tri-State Medical Group | |
| Beaver, Pennsylvania, United States, 15009 | |
| Bryn Mawr Hospital | |
| Bryn Mawr,, Pennsylvania, United States, 19010 | |
| Franklin County Heart Center at Summit Cardiology | |
| Chambersburg, Pennsylvania, United States, 17201 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Doylestown Hospital | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Harrisburg Hospital / Pinnacle Health | |
| Harrisburg, Pennsylvania, United States, 17110 | |
| Lancaster Heart & Stroke Foundation | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Hahnemann Hospital | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Penn Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| The Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Holy Spirit Hospital | |
| Wormleysburg, Pennsylvania, United States, 17043 | |
| Main Line Health Heart Center/The Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| York Hospital | |
| York, Pennsylvania, United States, 17405 | |
| United States, Rhode Island | |
| The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| AnMed Health | |
| Anderson, South Carolina, United States, 29621 | |
| Providence Hospital-SC | |
| Columbia, South Carolina, United States, 29204 | |
| United States, South Dakota | |
| Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Tennessee | |
| Memorial Health System | |
| Chattanooga, Tennessee, United States, 37404 | |
| West Clinic d/b/a Memphis Heart Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| St. Thomas Hospital | |
| Nashville, Tennessee, United States, 37205 | |
| Vanderbilt Vniversity Medical Center | |
| Nashville, Tennessee, United States, 37205 | |
| Centennial Heart Cardiovascular Consultants, LLC. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Amarillo Heart Clinical Research Institute | |
| Amarillo, Texas, United States, 79106 | |
| Capital Cadiovascular Specialists | |
| Austin, Texas, United States, 78745 | |
| Baylor Heart and Vascular Hospital | |
| Dallas, Texas, United States, 75226 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Lubbock Heart Hospital | |
| Lubbock, Texas, United States, 79416 | |
| Permian Research Foundation | |
| Odessa, Texas, United States, 79761 | |
| South Texas Methodist Hospital | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Salt Lake City, Utah, United States, 84103 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Cardiovascular Consultants | |
| Fredericksburg, Virginia, United States, 22401 | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| Carilion Roanoke Memorial | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Washington | |
| Overlake Hospital Medical Center | |
| Bellevue, Washington, United States, 98004 | |
| Providence Everett Medical Center | |
| Everett, Washington, United States, 98206 | |
| St. Joseph's Tacoma | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| St Mary's Medical Hospital | |
| Huntington, West Virginia, United States, 25701 | |
| United States, Wisconsin | |
| Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Wisconsin Heart Hospital | |
| Wauwatosa, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Abbott Vascular
Harvard Clinical Research Institute
Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo Inc.
Investigators
| Principal Investigator: | James Hermiller, MD | Heart Center of Indianapolis |
| Principal Investigator: | Mitch Krucoff, MD | Duke University |
More Information
No publications provided
| Responsible Party: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT01106534 History of Changes |
| Other Study ID Numbers: | 06-374C |
| Study First Received: | April 16, 2010 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott Vascular:
|
drug eluting stents Stents Angioplasty Stent thrombosis antiplatelet treatment |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Ischemia Vascular Diseases Coronary Occlusion Coronary Stenosis Coronary Restenosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
Clopidogrel Prasugrel Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013