DAPHNE Study: Direct Anticoagulant PHarmacogeNEtic
Palabras clave
Abstracto
fechas
Verificado por última vez: | 02/29/2020 |
Primero enviado: | 04/06/2017 |
Inscripción estimada enviada: | 04/06/2017 |
Publicado por primera vez: | 04/12/2017 |
Última actualización enviada: | 03/22/2020 |
Última actualización publicada: | 03/23/2020 |
Fecha de inicio real del estudio: | 06/27/2017 |
Fecha estimada de finalización primaria: | 03/31/2020 |
Fecha estimada de finalización del estudio: | 09/30/2020 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: CYP3A4/5 and P-gp phenotyping
Genetic: CYP3A4/5 and P-gp genotyping
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Patient under Rivaroxaban | |
Patient under Apixaban |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Método de muestreo | Non-Probability Sample |
Acepta voluntarios saludables | si |
Criterios | 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 |
Salir
Medidas de resultado primarias
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]
Medidas de resultado secundarias
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]
Otras medidas de resultado
1. Comparison bleeding management outcomes [6 weeks]