XIENCE 28 USA Study (NCT03815175) | Clinical Trial Compass
CompletedNot Applicable
XIENCE 28 USA Study
United States1,605 participantsStarted 2019-02-25
Plain-language summary
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System \[EECSS\], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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 \> 1-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.
✓. 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/mm3, or any known coagulation disorder associated with increased bleeding risk).
✓. Anemia with hemoglobin \< 11g/dl.
Exclusion criteria
✕. 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.
What they're measuring
1
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile
Timeframe: From 1 to 6 months
2
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile
Timeframe: From 6 to 12 months
3
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile
. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 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 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
✕. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month 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. Transferring to the XIENCE 90 study will not be an exclusion criterion.