non valvular atrial fibrillation
Conditions
Interventions
Trade Name: xarelto
rivaroxaban
Pharmaceutical Form: Film-coated tablet
Trade Name: Pradaxa
dabigatran
Pharmaceutical Form: Capsule, hard
Sponsors
MUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women aged 18 to 80 years newly diagnosed with non valvular AF • Signed written consent to take part in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Previous history of thrombotic or major bleeding event • Known to have prothrombotic risk factors • Use of oral anticoagulants • Creatinine clearance < 30 ml/min • Heart valve problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation. In addition, we want to investigate whether there is a correlation between the in-vivo effect and ex- vivo effect in a patient by spiking blood of patients before treatment with rivaroxaban or the active metabolite of dabigatran. ;Secondary Objective: not applicable;Primary end point(s): The main study parameter is thrombin generation. In addition, liver enzymes and renal function will be measured, as well as several additional tests for coagulation status. The end-point will be the variation in anticoagulant effect in different patients and the correlation between in vivo and in vitro (anticoagulant) effects of rivaroxaban or dabigatran. ;Timepoint(s) of evaluation of this end point: 0= before start of study medication 1= 1 week after start of study medication 2= two weeks after start of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: timepoint 0 (before start of medication) timepoint 1 (after 7 days) timepoint 2 (after 14 days) | — |
Countries
Netherlands
Contacts
Public Contactdepartment of biochemistry
MUMC
Outcome results
None listed