Addressing Real-world Anticoagulant Management Issues in Stroke

NCT02478177 | Completed DMC

• 1 other identifier: Pro00059817
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Stroke; Intracerebral Hemorrhage

Keywords

Anticoagulant; Stroke; Ischemic Stroke; Intracerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

• Prevalence of novel oral anticoagulants among patients with either acute ischemic stroke or intracerebral hemorrhage

  Prevalence of novel oral anticoagulants will be abstracted from the medical record

  Baseline

Secondary Outcomes (7)

• Number of Symptomatic intracranial hemorrhage events in ischemic stroke patients treated with tissue plasminogen activator (tPA)

  Within 36 hours of tPA treatment

• Percentage of Symptomatic intracranial hemorrhage events in ischemic stroke patients treated with tissue plasminogen activator (tPA)

  Within 36 hours of tPA treatment

• Modified Rankin Scale

  Patients will be assessed at discharge as well as 3 months and 6 months after discharge

• In-hospital mortality rate

  In-hospital mortality will be assessed for the duration of the patient's hospital stay (estimated 3-5 days)

• tPA treatment rate

  tPA treatment will be assessed within 24 hours of admission

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Janssen, LP: collaborator
• Genentech, Inc.: collaborator
• Daiichi Sankyo: collaborator
• American Heart Association: collaborator

Study Sites (1)

300 West Morgan Street, Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying Xian, MD, PhD

  Duke UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 23, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 26, 2020

Record last verified: 2019-04

Locations

US (1)