Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran
研究概览
简要总结
In patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the level of adherence will be measured using a questionnaire, the Danish National Prescription Registry and pillcount and will be related to plasma levels of dabigatran measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) and coagulation assays. The aim of the study is to measure the level of adherence and evaluate the usefulness of different coagulation assays to measure adherence in these patients. Furthermore, the aim is to determine the correlation between the anticoagulant effect of dabigatran using different coagulation assays and plasma levels of dabigatran.
Most studies so far have been performed in vitro with plasma samples spiked with dabigatran. In this study the present knowledge from results of coagulation assays in dabigatran spiked plasma samples will be compared to the results of coagulation assays using blood samples from real-life patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Non-valvular atrial fibrillation
- •Indication for dabigatran etexilate
排除标准
- •Use of anticoagulant medication within the last month
- •Contra-indication to dabigatran etexilate
- •Unable or not wishing to give informed consent
结局指标
主要结局
Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran
时间窗: 2 years
Measured by pillcount, bloodtests, the Danish National Prescription Registry and the Morisky Medication Adherence Scale
次要结局
- Prothrombin time(2 years)
- Height(2 years)
- Side-effects(2 years)
- Ecarin chromogenic assay(2 years)
- Kidney function(2 years)
- Medication persistence(2 years)
- Waist circumference(2 years)
- Activated partial thromboplastin time(2 years)
- Patient treatment satisfaction(2 years)
- Dabigatran plasma concentrations(2 years)
- Weight(2 years)
- Diluted thrombin time (calibrated for dabigatran)(2 years)
- ROTEM(2 years)
研究者
Willemijn Comuth
Cardiologist, PhD-fellow
Hospitalsenheden Vest