Clinical trial NCT02478177: Addressing Real-world Anticoagulant Management Issues in Stroke
Official title: Management of Acute Stroke Patients on Treatment With Novel Oral Anticoagulants: Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cerebrovascular Stroke
Intracerebral Hemorrhage
Keywords: Anticoagulant
Stroke
Ischemic Stroke
Intracerebral hemorrhage
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Janssen, LP
name: Genentech, Inc.
name: Daiichi Sankyo
name: American Heart Association
First posted: 2015-06-23
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of novel oral anticoagulants among patients with either acute ischemic stroke or intracerebral hemorrhage
timeFrame: Baseline
Secondary outcomes:
measure: Number of Symptomatic intracranial hemorrhage events in ischemic stroke patients treated with tissue plasminogen activator (tPA)
timeFrame: Within 36 hours of tPA treatment
measure: Percentage of Symptomatic intracranial hemorrhage events in ischemic stroke patients treated with tissue plasminogen activator (tPA)
timeFrame: Within 36 hours of tPA treatment
measure: Modified Rankin Scale
timeFrame: Patients will be assessed at discharge as well as 3 months and 6 months after discharge
measure: In-hospital mortality rate
timeFrame: In-hospital mortality will be assessed for the duration of the patient's hospital stay (estimated 3-5 days)
measure: tPA treatment rate
timeFrame: tPA treatment will be assessed within 24 hours of admission
measure: Number of intracerebral hemorrhage patients receiving anticoagulation reversal treatment
timeFrame: During the acute phase, usually within 24 hours of admission
measure: Percentage of intracerebral hemorrhage patients receiving anticoagulation reversal treatment
timeFrame: During the acute phase, usually within 24 hours of admission
Other outcomes:
Locations:
city: Durham
country: United States
facility: 300 West Morgan Street, Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Ying Xian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: