XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
A Safety Evaluation of 3-month Dual Antiplatelet Therapy in Subjects at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention With XIENCE.
1 other identifier
interventional
2,047
1 country
101
Brief Summary
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents. The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS, XIENCE PRO\^X EECSS \[rebrand of the XIENCE Xpedition Stent System and is only available outside of the United States (OUS)\], XIENCE PRO\^A EECSS (rebrand of the XIENCE Alpine Stent System and is only available OUS) and XIENCE Sierra EECSS of coronary drug-eluting stents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Typical duration for not_applicable
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 17, 2017
CompletedStudy Start
First participant enrolled
July 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2020
CompletedResults Posted
Study results publicly available
November 5, 2021
CompletedNovember 5, 2021
October 1, 2021
3.1 years
July 13, 2017
August 25, 2021
October 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block, development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI: CK-MB \> URL or Troponin \> URL with baseline value \< UR The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome \& the baseline demographic, clinical and procedural covariates as the predictors
From 3 to 12 months
Secondary Outcomes (11)
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
From 3 to 12 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable)
From 3 to 12 months
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
From 3 to 12 months
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
From 3 to 12 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
From 3 to 12 months
- +6 more secondary outcomes
Study Arms (1)
XIENCE
EXPERIMENTALSubjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
Interventions
3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days. Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
Eligibility Criteria
You may qualify if:
- Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with \> 3-month DAPT outweighs the benefit:
- ≥ 75 years of age.
- Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.
- History of major bleeding which required medical attention within 12 months of the index procedure.
- History of stroke (ischemic or hemorrhagic).
- Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
- Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count \<100,000/mm\^3, or any known coagulation disorder associated with increased bleeding risk).
- Anemia with hemoglobin \< 11g/dl.
- Subject must be at least 18 years of age.
- Subject or a legally authorized representative must provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
- Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, if eligible per protocol.
- Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
- Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note:
- The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the patient must not have \>2 lesions requiring treatment within both the LAD and a diagonal branch in total.
- If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
- +4 more criteria
You may not qualify if:
- Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
- Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Subject with implantation of another drug-eluting stent (other than XIENCE) within 9 months prior to index procedure.
- Subject has a known left ventricular ejection fraction (LVEF) \<30%.
- Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
- Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure.
- Subject with a current medical condition with a life expectancy of less than 12 months.
- Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Note: Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population
- Subject is part of a vulnerable population, defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Target lesion is in a left main location.
- Target lesion is located within an arterial or saphenous vein graft.
- Target lesion is restenotic from a previous stent implantation.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
Huntsville Hospital (Heart Center Research LLC)
Huntsville, Alabama, 35801, United States
Scottsdale Healthcare Hospitals (d/b/a HonorHealth - HonorHealth Research Institute)
Scottsdale, Arizona, 85258, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
John Muir Health Concord
Concord, California, 94520, United States
Washington Hospital (Mission Cardiovascular Research Institute)
Fremont, California, 94538, United States
Scripps Memorial Hospital/Prebys Cardiovascular Institute
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Sharp Grossmont Hospital (La Mesa Cardiac Center)
San Diego, California, 91942, United States
Sharp Memorial Hospital / San Diego Cardiac Center
San Diego, California, 92123, United States
Santa Barbara Cottage Hospital/Sansum Clinic
Santa Barbara, California, 93105, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
Medstar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Clearwater Cardiovasular Consultants
Clearwater, Florida, 33756, United States
Morton Plant Mease Healthcare System
Clearwater, Florida, 33756, United States
North Florida Regional / The Cardiac and Vascular Institute
Gainesville, Florida, 32605, United States
St. Vincent's Medical Center (St. Vincent's Healthcare)
Jacksonville, Florida, 32204, United States
Tallahassee Memorial Hospital / Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308, United States
University Health, INC/University Cardiology Associates, LLC
Augusta, Georgia, 30901, United States
Augusta Medical Center
Augusta, Georgia, 30912, United States
Atlanta Veterans Affairs Medical Center
Decatur, Georgia, 30033, United States
North Georgia Heart Foundation, Inc.
Gainesville, Georgia, 30501, United States
St. John's Hospital
Springfield, Illinois, 62701, United States
Elkhart General Hospital/Midwest Cardiology Research & Education Foundation
Elkhart, Indiana, 46514, United States
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Cardiovascular Research Institute of Kansas/Via Christi Regional Medical
Wichita, Kansas, 67226, United States
Kansas Heart Hospital (Cardiovascular Research Institute of Kansas)
Wichita, Kansas, 67226, United States
University of Kentucky/Gill Heart and Vascular Institute
Lexington, Kentucky, 40536, United States
Baptist Health Louisville/Louisville Cardiology
Louisville, Kentucky, 40207, United States
Eastern Maine Medical Center/One Northeast Drive
Bangor, Maine, 04401, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic/Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
McLaren Bay Region
Bay City, Michigan, 48708, United States
St John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Genesys Regional Medical Center (Regional Cardiology Associates)
Grand Blanc, Michigan, 48439, United States
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49048, United States
MidMichigan Medical Center Midland
Midland, Michigan, 48670, United States
Traverse Heart and Vascular Munson Medical Center
Traverse City, Michigan, 49684, United States
St. Joseph Mercy Hospital (Michigan Heart)
Ypsilanti, Michigan, 48197, United States
Abbott Northwestern Hospital (Minneapolis Heart Institute Foundation)
Minneapolis, Minnesota, 55407, United States
CentraCare
Saint Cloud, Minnesota, 56303, United States
St Dominic-Jackson Memorial Hospital (Jackson Heart Clinic)
Jackson, Mississippi, 39216, United States
North Mississippi Medical Center (Cardiology Associates Research)
Tupelo, Mississippi, 38801, United States
Boone Hospital Center (Missouri Cardiovascular Specialists)
Columbia, Missouri, 65201, United States
St. Luke's Hospital/Mid America Heart Institute
Kansas City, Missouri, 64111, United States
Washington University School of Medicine Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
St. Patrick Hospital International Heart Institute of Montana Foundation
Missoula, Montana, 59802, United States
Bryan Local General Hospital (Bryan Medical Center East)
Lincoln, Nebraska, 68506, United States
Our Lady of Lourdes/Cardiovascular Associates of the Delaware Valley (The Heart House)
Camden, New Jersey, 08035, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
St. Joseph's Hospital Health Center
East Syracuse, New York, 13057, United States
New York - Presbyterian Queens Lang Research Center
Flushing, New York, 11355, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
New York Presbyterian Hospital - Weill Cornell
New York, New York, 10065, United States
Lenox Hill Hospital (Northwell)/ Feinstein Institute
New York, New York, 10075, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-8167, United States
The Presbyterian Hospital (d/b/a Novant Health Heart and Vascular Institute) Novant Health Clinical Research
Charlotte, North Carolina, 28204, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Wake Forest Baptist Medical Center (Wake Forest University Health Sciences)/Medical Center Boulevard
Winston-Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44266, United States
Cardiovascular Research Center, LLC (Mercy Health St. Vincent Medical Center LLC)
Toledo, Ohio, 43608, United States
Integris Baptist Medical Center/Integris Cardiovascular Physicians, LLC
Oklahoma City, Oklahoma, 73112, United States
Hillcrest Medical Center (Oklahoma Heart Institute)
Tulsa, Oklahoma, 74104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
UPMC Hamot/Medicor Associates, Inc.,
Erie, Pennsylvania, 16507, United States
Harrisburg Hospital/Pinnacle Health Cardiovascular Institute, Inc.
Harrisburg, Pennsylvania, 17101, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Penn Presbyterian Medical Center/Penn Heart and Vascular Pavilion,
Philadelphia, Pennsylvania, 19104, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15220, United States
St. Joseph Medical Center
Wyomissing, Pennsylvania, 19610, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
AnMed Health Clinical Research
Anderson, South Carolina, 29621, United States
Sanford Health
Sioux Falls, South Dakota, 57105, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
Turkey Creek Medical Center (Knoxville HMA Cardiology, LLC)
Knoxville, Tennessee, 37934, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Centennial Medical Center (TriStar Centennial Medical Center)
Nashville, Tennessee, 37203, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Memorial Hermann-Hermann Hospital/UTHealth
Houston, Texas, 77030, United States
Texas Tech University Health (University Medical Center)
Lubbock, Texas, 79430-7520, United States
East Texas Medical Center
Tyler, Texas, 75701, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Inova Fairfax Hospital/Inova Heart and Vascular Institute
Falls Church, Virginia, 22042, United States
Mary Washington Hospital/Virginia Cardiovascular Consultants
Fredericksburg, Virginia, 22401, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Charleston Area Medical Center Memorial Division
Charleston, West Virginia, 25304, United States
Related Publications (2)
Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074.
PMID: 34794687DERIVEDValgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.
PMID: 33031789DERIVED
Results Point of Contact
- Title
- Lijuan Jenn Wang, Advisor, Clinical Affairs
- Organization
- Abbott
Study Officials
- PRINCIPAL INVESTIGATOR
Roxana Mehran
Abbott Medical Devices
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 17, 2017
Study Start
July 19, 2017
Primary Completion
September 4, 2020
Study Completion
September 4, 2020
Last Updated
November 5, 2021
Results First Posted
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share