The effect of body weight on the medicine concentrations of dabigatran, edoxaban, apixaban and rivaroxaban in blood.
Phase 1
- Conditions
- o medical condition will be investigated. This study will only investigate the effect of body weight on through concentrations of direct oral anticoagulants (DOACs)Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2017-003569-91-NL
- Lead Sponsor
- Hagaziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- Male or female = 18 years
- Treated with a DOAC (rivaroxaban, dabigatran, apixaban, edoxaban) in a therapeutic or prophylactic dosage for at least three days
- Is not mentally disabled
- Good understanding of the Dutch language
- Written informed consent
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- Collected blood sample is not a trough concentration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of body weight on the trough concentrations of DOACs in patients. ;Secondary Objective: - To investigate the effect of body weight on anti-Factor Xa (FXa) activity for apixaban, rivaroxaban and edoxaban. <br>- To investigate the effect of body weight on anti-Factor IIa (FIIa) activity for dabigatran.<br>;Primary end point(s): The DOAC trough concentration;Timepoint(s) of evaluation of this end point: One year after initial start of the BC_DOAC study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The anti-Factor Xa (FXa) activity for apixaban, rivaroxaban and edoxaban. <br>- The anti-Factor IIa (FIIa) activity for dabigatran.<br>;Timepoint(s) of evaluation of this end point: One year after initial start of the BC_DOAC study