Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144866
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-11-17
Brief Title:
Evaluataion of NOAC Levels in Acute Stroke
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None