XIENCE 28 USA Study
Condition: Bleeding Disorder; Ischemic Stroke; Hemorrhagic Stroke; Hematological Diseases; Thrombocytopenia; Coagulation Disorder; Anemia; Renal Insufficiency; Coronary Artery Disease
MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke; Renal Insufficiency; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hemostatic Disorders; Thrombocytopenia; Blood Coagulation Disorders; Hematologic Diseases
Study type: Interventional

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.
    

Detailed description: 
      The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE
      implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be
      registered from approximately 50 sites in the United States and Canada. Subject registration
      is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be
      assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat
      coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1
      month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant
      with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for
      > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor
      inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month
      follow-up.

      All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The
      data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28
      Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex
      HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA
      Study.
    

Intervention name(s): XIENCE; DAPT (aspirin and/or P2Y12 receptor inhibitor)
Intervention type(s): Device; Drug
Intervention description(s): Subjects who received XIENCE family stent systems will be included.; "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Other intervention name(s): Dual antiplatelet therapy
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Bleeding Risk (HBR); Dual antiplatelet therapy (DAPT); Drug eluting stent (DES); XIENCE; Percutaneous coronary intervention (PCI); Coronary Artery Disease