Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06144866 |
| Other study ID # |
202003059RINA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2023 |
| Source |
National Taiwan University Hospital |
| Contact |
Shin Yi Lin, M.S. |
| Phone |
+88623123456 |
| Email |
hsin924[@]ntuh.gov.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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. 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.
Description:
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:
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.
