title: Acute management of stroke patients taking non-vitamin K antagonist oral anticoagulants Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry: Design and rationale.
abstract: BACKGROUND
  Non-vitamin K antagonist oral anticoagulants (NOACs, dabigatran, rivaroxaban, apixaban, and edoxaban) have been increasingly used as alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation. Yet there is substantial lack of information on how patients on NOACs are currently treated when they have an acute ischemic stroke and the best strategies for treating intracerebral hemorrhage for those on chronic anticoagulation with warfarin or a NOAC. These are critical unmet needs for real world clinical decision making in these emergent patients.
  
  
  METHODS
  The ARAMIS Registry is a multicenter cohort study of acute stroke patients who were taking chronic anticoagulation therapy prior to admission and are admitted with either an acute ischemic stroke or intracerebral hemorrhage. Built upon the existing infrastructure of American Heart Association/American Stroke Association Get With the Guidelines Stroke, the ARAMIS Registry will enroll a total of approximately 10,000 patients (5000 with acute ischemic stroke who are taking a NOAC and 5000 with anticoagulation-related intracerebral hemorrhage who are on warfarin or a NOAC). The primary goals of the ARAMIS Registry are to provide a comprehensive picture of current treatment patterns and outcomes of acute ischemic stroke patients on NOACs, as well as anticoagulation-related intracerebral hemorrhage in patients on either warfarin or NOACs. Beyond characterizing the index hospitalization, up to 2500 patients (1250 ischemic stroke and 1250 intracerebral hemorrhage) who survive to discharge will be enrolled in an optional follow-up sub-study and interviewed at 3 and 6 months after discharge to assess longitudinal medication use, downstream care, functional status, and patient-reported outcomes.
  
  
  CONCLUSIONS
  The ARAMIS Registry will document the current state of management of NOAC treated patients with acute ischemic stroke as well as contemporary care and outcome of anticoagulation-related intracerebral hemorrhage. These data will be used to better understand optimal strategies to care for these complex but increasingly common emergent real world clinical challenges.
authors.affiliation: Duke Clinical Research Institute, Durham, NC; Department of Neurology, Duke University Medical Center, Durham, NC. Electronic address: ying.xian@duke.edu.
authors.forename: Ying
authors.initials: Y
authors.lastname: Xian
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Tina
authors.initials: T
authors.lastname: Harding
authors.affiliation: Division of Cardiology, University of California, Los Angeles, CA.
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: Department of Emergency Medicine, University of Texas Southwestern, Dallas, TX.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Suter
authors.affiliation: American Heart Association, Massachusetts General Hospital, Boston, MA.
authors.forename: Yosef
authors.initials: Y
authors.lastname: Khan
authors.affiliation: Department of Neurology, Massachusetts General Hospital, Boston, MA.
authors.forename: Lee H
authors.initials: LH
authors.lastname: Schwamm
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy; D015331:Cohort Studies; D000069604:Dabigatran / Q000008:administration & dosage / Q000009:adverse effects; D004638:Emergency Treatment / Q000379:methods / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D054539:Medication Therapy Management / Q000592:standards; D010043:Outcome and Process Assessment, Health Care; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects; D011728:Pyridones / Q000008:administration & dosage / Q000009:adverse effects; D058996:Quality Improvement; D012042:Registries; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control / Q000628:therapy; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects; D014481:United States / Q000453:epidemiology; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D011720:Pyrazoles; D011725:Pyridines; D011728:Pyridones; D013844:Thiazoles; C522181:apixaban; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran; C552171:edoxaban