Monitoring of NOAC Therapy: Standardizing Reference Intervals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- NOAC level in blood
研究概览
简要总结
This study is aimed to establish reference intervals of NOAC (dabigatran, apixaban and rivaroxaban) in ethnic Chinese patients.
详细描述
360 patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited. After the informed consent, the patient will be needed for blood taking before and 2 hours after the medication (NOAC). The patient's demographic data and medical history will also be retreived from Central Medical Syetem too.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ethnic Chinese ONLY
- •18 years old or above
- •Non-valvular atrial fibrillation
- •Duration of NOAC use at least 3 months
- •No changes in NOAC dosage or type within 3 months
- •Creatinine Clearance (by Cockcroft-Gault formula) >/=30mL/min
排除标准
- •Valvular atrial fibrillation or no atrial fibrillation
- •Recent haemorrhage or ischemia within 1 year
- •Active liver disease
- •Abnormal baseline clotting profile
- •Abnormal baseline thrombocytopenia or thrombocytosis
- •Thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein C, S, anti-thrombin III deficiency)
- •Non-compliant patients, defined as missing any doses of NOAC in recent 1 month
- •Anticoagulation for disorders other than AF
研究组 & 干预措施
Ischemic stroke patient
Ischemic stroke patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited from the Prince of Wales Hospital, either in-patient or out-patient clinic
结局指标
主要结局
NOAC level in blood
时间窗: One week after the recruitment
The NOAC level in blood before and after the medication
次要结局
未报告次要终点
研究者
Dr. IP Yiu Ming Bonaventure
Specialist Resident
Chinese University of Hong Kong