Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2020-05-01
2025-12-31
Brief Summary
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The relationship between NOACs exposure and safety has been elucidated in large-scale clinical trials. As the NOACs level increased, the risk for bleeding increased, too. Nevertheless, no additional protection was noted with increased NOACs levels. In post marketing surveillance, bleeding and thrombotic events have been reported. Investigating the NOACs level among these patients helps evaluating the residual drug in the body, which could be a reference for clinical decision in emergent situation.
Specific purpose: Investigate the correlation between NOACs concentration upon the arrival of emergency department (ED) and important clinical outcomes including systemic thromboembolism, and major bleeding.
Direction for investigation:
1. Prospectively record the NOACs concentration among AF patients under NOACs therapy and suffered from ischemic stroke (IS), transient ischemic attack (TIA), intracerebral hemorrhage (ICH) and other major bleeding.
2. Investigate the correlation between NOACs concentration upon ED arrival and thromboembolic or bleeding events.
3. Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.
Detailed Description
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The relationship between NOACs exposure and safety has been elucidated in large-scale clinical trials. As the NOACs level increased, the risk for bleeding increased, too. Nevertheless, no additional protection was noted with increased NOACs levels. In post marketing surveillance, bleeding and thrombotic events have been reported. Investigating the NOACs level among these patients helps evaluating the residual drug in the body, which could be a reference for clinical decision in emergent situation.
Specific purpose:
1. Prospectively record the NOACs concentration among AF patients under NOACs therapy and suffered from IS, TIA, ICH or major bleeding.
AF patients who presented to emergent department (ED) for acute IS, TIA, ICH (non-traumatic), or other major bleeding and was under NOACs therapy will be recruited to this study. Blood sample will be collected before acute management to measure NOACs concentration. Co-morbid disease, laboratory tests and concurrent medications will be retrieved from electronic medical records. The onset, location, severity of IS. ICH or other major bleeding, and the outcome and long-term managements will be prospectively recorded.
2. Investigate the correlation between NOACs concentration and thromboembolic or bleeding events.
For each NOACs, we are going to compare the differences in NOACs exposure between patients with thromboembolism or major bleedi. Important baseline characteristics, co-medications and disease severity will be adjusted before making comparison.
3. Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.
From the data of NOACs concentration among patients with IS or ICH, we plan to propose a therapeutic range with acceptable efficacy and safety for NOACs therapy. Our data will provide a guide for physicians to make important clinical decision.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Dabigatran, rivaroxaban, apixaban, edoxaban
For patients who received direct oral anticoagulants (DOAC) before ischemic stroke or intracranial hemorrhage, the DOAC level upon hospital arrival will be measured.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Having AF diagnosis
3. Under NOACs therapy including dabigatran, rivaroxaban, apixaban and edoxaban.
4. Admitted for acute IS, transient ischemic attack (TIA), ICH or major bleeding
Exclusion Criteria
2. Decline the inform consent.
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Clinical Trial Center
Pharmacist
Principal Investigators
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Shin Yi Lin, M.S.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202003059RINA
Identifier Type: -
Identifier Source: org_study_id