DAPHNE Study: Direct Anticoagulant PHarmacogeNEtic
Cuvinte cheie
Abstract
Datele
Ultima verificare: | 02/29/2020 |
Primul depus: | 04/06/2017 |
Inscriere estimată trimisă: | 04/06/2017 |
Prima postare: | 04/12/2017 |
Ultima actualizare trimisă: | 03/22/2020 |
Ultima actualizare postată: | 03/23/2020 |
Data actuală de începere a studiului: | 06/27/2017 |
Data estimată de finalizare primară: | 03/31/2020 |
Data estimată de finalizare a studiului: | 09/30/2020 |
Stare sau boală
Intervenție / tratament
Diagnostic Test: CYP3A4/5 and P-gp phenotyping
Genetic: CYP3A4/5 and P-gp genotyping
Fază
Grupuri de brațe
Braţ | Intervenție / tratament |
---|---|
Patient under Rivaroxaban | |
Patient under Apixaban |
Criterii de eligibilitate
Vârste eligibile pentru studiu | 18 Years La 18 Years |
Sexe eligibile pentru studiu | All |
Metoda de eșantionare | Non-Probability Sample |
Acceptă voluntari sănătoși | da |
Criterii | 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 |
Rezultat
Măsuri de rezultate primare
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]
Măsuri de rezultate secundare
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]
Alte măsuri de rezultat
1. Comparison bleeding management outcomes [6 weeks]