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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Functional outcome
研究概览
简要总结
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:
- 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.
- Investigate the correlation between NOACs concentration upon ED arrival and thromboembolic or bleeding events.
- Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.
详细描述
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:
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •The ICH is resulted from trauma.
- •Decline the inform consent.
结局指标
主要结局
Functional outcome
时间窗: 3 months after stroke (ischemic or hemorrhagic)
Functional status measured by using the modified Rankin Scale.
次要结局
- Recurrent ischemic stroke(3 years)
- Successful reperfusion (in ischemic stroke patients receiving endovascular thrombectomy)(Evaluated after EVT)
- Recurrent intracranial hemorrhage(3 years)
- Symptomatic intracranial hemorrhage (sICH)(24-36 hours after stroke)
- Early neurological improvement(24 hours after stroke)
研究者
National Taiwan University Clinical Trial Center
Pharmacist
National Taiwan University Hospital