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NCT Number: NCT05283174

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

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.

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Shin Yi Lin, MS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling to test drug level

Other

To collect blood sample during acute stroke and measure NOAC concentration.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shin Yi Lin, MS

CONTACT

[email protected]

0972651956

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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