DAPHNE Study: Direct Anticoagulant PHarmacogeNEtic
关键词
抽象
日期
最后验证: | 02/29/2020 |
首次提交: | 04/06/2017 |
提交的预估入学人数: | 04/06/2017 |
首次发布: | 04/12/2017 |
上次提交的更新: | 03/22/2020 |
最近更新发布: | 03/23/2020 |
实际学习开始日期: | 06/27/2017 |
预计主要完成日期: | 03/31/2020 |
预计完成日期: | 09/30/2020 |
状况或疾病
干预/治疗
Diagnostic Test: CYP3A4/5 and P-gp phenotyping
Genetic: CYP3A4/5 and P-gp genotyping
相
手臂组
臂 | 干预/治疗 |
---|---|
Patient under Rivaroxaban | |
Patient under Apixaban |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Understanding of French or English language and provide signed and dated informed consent form. - Willing to comply with all study procedures and be available for the duration of the study. - Male or female, aged 18 years or above. - Diagnosed with atrial fibrillation, deep-vein thrombosis or pulmonary embolism and under rivaroxaban or apixaban drug treatment. Exclusion Criteria: - Participation in a clinical study that may interfere with participation in this study. - Under rivaroxaban or apixaban for prophylaxis of deep-vein thrombosis and pulmonary embolism in patients undergoing knee or hip replacement surgery. - Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. - Known allergy to midazolam or to fexofenadine |
结果
主要结果指标
1. Comparison Apixaban Area Under the Curve (AUC) according to patient CYP3A phenotype [6 weeks]
2. Comparison Rivaroxaban AUC according to patient P-gp phenotype [6 weeks]
3. Comparison Apixaban AUC according to patient CYP3A genotype [6 weeks]
4. Comparison Rivaroxaban AUC according to patient P-gp genotype [6 weeks]
次要成果指标
1. Comparison Apixaban AUC according to patient hepatic function [6 weeks]
2. Comparison Rivaroxaban AUC according to patient hepatic function [6 weeks]
3. Comparison Apixaban AUC according to patient renal function [6 weeks]
4. Comparison Rivaroxaban AUC according to patient renal function [6 weeks]
5. Comparison adverse event (bleeding) occurrence according to patient CYP3A phenotype [6 weeks]
6. Comparison adverse event (bleeding) occurrence according to patient P-gp phenotype [6 weeks]
其他成果措施
1. Comparison bleeding management outcomes [6 weeks]