Addressing Real-world Anticoagulant Management Issues in Stroke

The ARAMIS Registry is a multicenter, cohort study of patients presenting with acute ischemic
stroke (AIS) or intracerebral hemorrhage (ICH) while taking chronic anticoagulation therapy.
The goals of ARAMIS are to (1) examine the prevalence of preadmission novel oral
anticoagulants use among patients with AIS or ICH; (2) describe and characterize coagulation
tests being used to assess the level of anticoagulation in these patients; (3) examine the
utilization and safety profile of thrombolytic therapy in AIS patients taking new classes of
anticoagulants; and (4) document treatment patterns of anticoagulation-related ICH and
compare how care and outcomes vary by novel oral anticoagulants and warfarin. The acquisition
of such findings will be of critical importance to help fill in gaps on guideline
recommendations and provide insights into the management of AIS and ICH patients on treatment
with new anticoagulants. This will allow physicians to feel more confident in anticoagulation
therapy while improving the care and outcomes of patients on these agents who have stroke
complications.

The ARAMIS builds upon the backbone of the nation's largest ongoing stroke registry, Get With
The Guidelines-Stroke (GWTG-Stroke) by the American Heart Association/American Stroke
Association (AHA/ASA). The GWTG-Stroke registry provides data on patient demographics,
medical history, laboratory results, brain imaging, in-hospital treatment and outcomes. Using
this existing resource, ARAMIS will create a new on-line supplemental data collection module
and specifically collect information on medications prior to admission, diagnostic testing,
treatment, factors associated with treatment decision making as well as clinical outcomes. A
total of 10,000 consecutive patients 18 years or older, who experience an AIS (n=5,000) while
taking a novel oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban) or have an
ICH (n=5,000) while taking warfarin or one of the novel oral anticoagulants within 7 days
prior to the stroke onset will be enrolled in approximately 3-4 years. Beyond the index
hospitalization, ARAMIS will enroll 2500 consecutive patients (1250 AIS and 1250 ICH) who
survive and provide informed consent at discharge for the follow-up study. Trained personnel
from the Duke Clinical Research Institute (DCRI) Call Center will conduct structured
telephone interviews with these patients at 3 and 6 months following their index
hospitalization. The follow-up interview will extend the baseline data collection at
GWTG-Stroke and ARAMIS and include long-term medication, downstream care, and
patient-reported outcomes, Obtaining such information will not only provide a longitudinal
perspective on care and outcomes, but will also allow for innovative patient-centered
outcomes and comparative effective research.

Inclusion Criteria:

- Age 18 years or older

- Have been diagnosed with acute ischemic stroke and have been treated with dabigatran,
rivaroxaban, apixaban, edoxaban within 7 days prior to admission, or

- Have been diagnosed with intracerebral hemorrhage and have been treated with warfarin
or one of the novel oral anticoagulants within 7 days prior to admission

- ARAMIS follow-up study: Ability of patient or legally authorized representative to
provide informed consent for longitudinal follow-up indicating they understand the
purpose and the requirements of the study and are willing to participate.

Exclusion Criteria:

- Patients who are transferred from another hospital (unless directly transferred from
another hospital emergency department (ED) within 24 hours) or discharged to other
acute care facility will be excluded.