Addressing Real-world Anticoagulant Management Issues in Stroke

NCT ID: NCT02478177

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Stroke; Cerebrovascular Stroke; Intracerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke

Patients who had an acute ischemic stroke while taking one of the novel oral anticoagulants or patients who had an intracerebral hemorrhage while taking warfarin or one of the novel oral anticoagulants

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

American Heart Association

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Xian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke UMC

Locations

300 West Morgan Street, Duke Clinical Research Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00059817

Identifier Type: -

Identifier Source: org_study_id