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The effect of body weight on the medicine concentrations of dabigatran, edoxaban, apixaban and rivaroxaban in blood.

The effect of body weight on trough concentrations of DOACs in patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22392
Enrollment
160
Registered
2018-01-31
Start date
2018-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DOAC, body weight, trough concentration DOAC, lichaamsgewicht, dalspiegel

Interventions

Patients will only use the licensed DOACs (Eliquis®, Xarelto® Lixiana® and Pradaxa®) as standard care prescribed by their physician. No intervention will take place, only DOAC trough concentrations wi

Sponsors

Haga Teaching Hospital and Central Hospital Pharmacy The Hague
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Male or female ≥ 18 years - Treated with a DOAC (rivaroxaban, dabigatran, apixaban, edoxaban) in a therapeutic or prophylactic dosage for at least 5 days - eGFR > 50 ml/min - Is not mentally disabled - Good understanding of the Dutch language - Written informed consent

Exclusion criteria

Exclusion criteria: - The use of relevant co-medication: Ketoconazole, Posaconazole, Voricanazole , Itraconazole , Fluconazole, HIV protease inhibitors, Ticagrelor , Verapamil , Diltiazem (except dabigatran) , Amiodarone , Quinidine, Cyclosporin, Tacrolimus, Clarithromycin, Erythromycin, Carbamazepine, Rifampicin, St John¡¯s wort, Phenytoin phenobarbital

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to investigate the effect of body weight on the trough concentrations of DOACs.

Secondary

MeasureTime frame
- To investigate the effect of body weight on anti-Factor Xa (FXa) activity for apixaban, rivaroxaban and edoxaban. - To investigate the effect of body weight on anti-Factor IIa (FIIa) activity for dabigatran.

Contacts

Public ContactJ.M. Borst

Haga Teaching Hospital, Central Hospital Pharmacy The Hague, The Netherlands

j.borst@hagaziekenhuis.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)