Evaluataion of NOAC Levels in Acute Stroke

NCT06144866 | Unknown

• 1 other identifier: 202003059RINA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended over warfarin in preventing stroke and thromboembolism among patients with atrial fibrillation (AF) in several guidelines. To evaluate the pharmacological effects of NOACs, directly measuring the concentration is the most arbitrary way since the correlation between concentration and common coagulation tests are not reliable. Our previous investigation reported under the fixed dose regimen, dabigatran exposure increased in elderly, renal impairments and patients with multiple co-morbid conditions. Our data also showed difference in NOACs exposure in Asians. For example, patients under rivaroxaban, in comparison to apxiaban, were more likely to have lower than expected range drug level. Furthermore, the NOACs concentration also affected by the prescription pattern of physicians (non-compliant to labeled dose) and patients' behavior (poor medication adherence). 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. 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. 2.Investigate the correlation between NOACs concentration upon ED arrival and thromboembolic or bleeding events.
3. 3.Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.

Conditions

Ischemic Stroke; Anticoagulant Adverse Reaction

Keywords

Ischemic stroke; Intracranial hemorrhage; Direct oral anticoagulant; Drug level

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  Functional status measured by using the modified Rankin Scale.

  3 months after stroke (ischemic or hemorrhagic)

Secondary Outcomes (5)

• Symptomatic intracranial hemorrhage (sICH)

  24-36 hours after stroke

• Early neurological improvement

  24 hours after stroke

• Successful reperfusion (in ischemic stroke patients receiving endovascular thrombectomy)

  Evaluated after EVT

• Recurrent ischemic stroke

  3 years

• Recurrent intracranial hemorrhage

  3 years

Interventions

Dabigatran, rivaroxaban, apixaban, edoxaban DRUG

For patients who received direct oral anticoagulants (DOAC) before ischemic stroke or intracranial hemorrhage, the DOAC level upon hospital arrival will be measured.

Also known as: Direct oral anticoagulants

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient under direct oral anticoagulant therapy and suffered from ischemic stroke or intracranial hemorrhage.

You may qualify if:

• Age ≥ 20 years
• Having AF diagnosis
• Under NOACs therapy including dabigatran, rivaroxaban, apixaban and edoxaban.
• Admitted for acute IS, transient ischemic attack (TIA), ICH or major bleeding

You may not qualify if:

• The ICH is resulted from trauma.
• Decline the inform consent.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, buffycoat

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages

Interventions

Dabigatran; Rivaroxaban; apixaban; edoxaban; N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Shin Yi Lin, M.S.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin Yi Lin, M.S.

CONTACT

+88623123456; hsin924@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 22, 2023
• Study Start: May 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)