Evaluating anticoagulant levels in patients with acute stroke
Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants Concentration Among Patients With Acute Stroke (The Direct Oral AntiCoagulant Registry in Taiwan-Emergent Department, DOACT-ED)
This study is testing the levels of certain blood-thinning medications in patients with atrial fibrillation who have had an acute stroke to see how these levels affect their recovery and safety.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06144866 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the levels of non-vitamin K antagonist oral anticoagulants (NOACs) in patients diagnosed with atrial fibrillation who are admitted for acute ischemic stroke or related conditions. It focuses on directly measuring the concentration of NOACs, such as dabigatran, rivaroxaban, apixaban, and edoxaban, to understand their pharmacological effects and safety profiles. The study will prospectively record NOAC levels and analyze how these levels correlate with patient outcomes, particularly in relation to bleeding risks and medication adherence. The findings could provide valuable insights for clinical decision-making in emergency situations involving anticoagulated patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years and older with a diagnosis of atrial fibrillation who are currently on NOAC therapy and admitted for acute ischemic stroke or related conditions.
Not a fit: Patients who have experienced intracranial hemorrhage due to trauma or those who decline to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of anticoagulant therapy in patients with acute stroke, potentially reducing the risk of adverse reactions.
How similar studies have performed: Previous studies have demonstrated the importance of monitoring NOAC levels, but this specific approach to evaluating levels in acute stroke patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 20 years 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: 1. The ICH is resulted from trauma. 2. Decline the inform consent.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Shin Yi Lin, M.S. — National Taiwan University Hospital
- Study coordinator: Shin Yi Lin, M.S.
- Email: hsin924@ntuh.gov.tw
- Phone: +88623123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.