Addressing Real-world Anticoagulant Management Issues in Stroke "ARAMIS"

Enrolling by invitation

Phase N/A Results N/A

Trial Description

The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulants in community practice.

Detailed Description

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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients who have had an acute ischemic stroke that has taken either dabigatran, rivaroxaban, apixaban, or edoxaban at least 7 days prior to admission OR patients who have had an intracerebral hemorrhage that has taken warfarin or one of the novel oral anticoagulants at least 7 days prior to admission.

Outcomes

Type Measure Time Frame Safety Issue
Primary Prevalence of novel oral anticoagulants among patients with either acute ischemic stroke or intracerebral hemorrhage Baseline No
Secondary Number of Symptomatic intracranial hemorrhage events in ischemic stroke patients treated with tissue plasminogen activator (tPA) Within 36 hours of tPA treatment No
Secondary Percentage of Symptomatic intracranial hemorrhage events in ischemic stroke patients treated with tissue plasminogen activator (tPA) Within 36 hours of tPA treatment No
Secondary Modified Rankin Scale Patients will be assessed at discharge as well as 3 months and 6 months after discharge No
Secondary In-hospital mortality rate In-hospital mortality will be assessed for the duration of the patient's hospital stay (estimated 3-5 days) No
Secondary tPA treatment rate tPA treatment will be assessed within 24 hours of admission No
Secondary Number of intracerebral hemorrhage patients receiving anticoagulation reversal treatment During the acute phase, usually within 24 hours of admission No
Secondary Percentage of intracerebral hemorrhage patients receiving anticoagulation reversal treatment During the acute phase, usually within 24 hours of admission No

Sponsors