The Association Between Non-vitamin K Antagonist Oral Anticoagulant Therapy and Acute Stroke Severity and Post Stroke Short-term and Long-term Outcomes.

March 8, 2022 updated by: National Taiwan University Hospital

Non-vitamin K antagonist oral anticoagulant (NOAC) is the first line therapy to prevent thromboembolism in atrial fibrillation (AF) patients. Previous investigation showed that preceding NOAC therapy was associated with lower severity of ischemic stroke, but with higher in-hospital mortality in intracerebral hemorrhage (ICH), as compared with antithrombotic agent non-users. Measurement of NOAC level upon acute stroke aids the critical decision of acute management. Real-world data regarding the relationship between the NOAC adherence, the appropriateness of NOAC regimen, or NOAC level in acute stroke and the stroke severity or short-term outcome is lacking. Further, optimal selection for long-term stroke prevention among patients with acute stroke during NOAC therapy remains unclear.

Specific purpose: To analyze the association between NOAC adherence or NOAC level upon acute stroke and stroke severity or stroke outcomes, and analyze the impact of starting or withholding antithrombotic therapy after acute stroke on long-term stroke outcomes.

Specific Aim (Year 1):

To investigate the relationship between NOAC adherence or appropriateness of NOAC dose and acute stroke severity or in-hospital mortality based on National Health Insurance Research Database (NHIRD). Another important goal is to prospectively establish a cohort of AF users who developed acute stroke during NOAC therapy in National Taiwan University Hospital (NTUH) (target: around 100 patients annually), measure the NOAC level upon hospital arrival, record stroke severity, 90-days functional outcomes, post-stroke antithrombotic agents and repeat stable NOAC level in patients who restart NOAC treatment.

Specific Aim (Year 2):

To investigate the relationship between post-stroke antithrombotic therapy, especially changing or retaining preceding NOAC and long-term stroke outcomes based on NHIRD. We will also keep enrolling the prospective cohort and follow the 1-year stroke outcome.

Specific Aim (Year 3):

To complete the process of study enrollment (total: 300 patients) and conduct statistical analysis. The main goal is to finish the Aim 1 and 2 based on NHIRD. In addition, to provide data of emergent NOAC level and stroke severity or short-term outcome, and post-stroke antithrombotic therapy and long-term outcomes based on the prospectively enrolled cohort.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Atrial fibrillation with NOAC therapy and subsequently develops acute stroke.

Description

Inclusion Criteria:

  • Atrial fibrillation
  • Under dabigatran, rivaroxaban, apixaban or edoxaban therapy.
  • Developing ischemic stroke, transient ischemic attack or intracranial hemorrhage during NOAC therapy.

Exclusion Criteria:

  • Refuse to provide blood sample for non-vitamin K antagonist oral anticoagulant (NOAC) concentration measurement.
  • Refuse to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness outcome
Time Frame: From the date of study enrollment to end of NOAC exposure, death, occurrence of aforementioned outcome (ischemic stroke, transient ischemic attack or systemic thromboembolism) or end of the study, whichever comes first, assessed up to 100 months.
Ischemic stroke, transient ischemic attack or systemic thromboembolism
From the date of study enrollment to end of NOAC exposure, death, occurrence of aforementioned outcome (ischemic stroke, transient ischemic attack or systemic thromboembolism) or end of the study, whichever comes first, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcome
Time Frame: From the date of study enrollment to end of NOAC exposure, death, occurrence of major or life-threatening bleeding, classified according to the PLATO criteria or end of the study.
Major or life-threatening bleeding
From the date of study enrollment to end of NOAC exposure, death, occurrence of major or life-threatening bleeding, classified according to the PLATO criteria or end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202112164RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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