Comparing daytime plasma levels of rivaroxaban with a morning versus evening dose

Comparing daytime plasma levels of rivaroxaban with a morning versus evening dose - TIME-X study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47973

Enrollment

Registered

2020-01-14

Start date

2020-12-11

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

thrombosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adults (>18 years) - Treated for venous thrombo-embolism with rivaroxaban 20 mg once daily for at least three months - Ingestion of rivaroxaban either in the morning with breakfast or in the evening with supper - Both breakfast and supper incorporated in daily dietary pattern

Exclusion criteria

Exclusion criteria: - Impaired renal function, i.e. estimated glomerular filtration rate 40 kg/m2 or weight of >120 kg - Liver cirrhosis - History of gastric- or bowelresection - Concomitant use of medication interacting with rivaroxaban (CYP3A4 inhibitors and P-glycoprotein inhibitors)

Design outcomes

Primary

Measure	Time frame
Plasma-levels of rivaroxaban during daytime, i.e. 14.00 p.m.,determined with liquid chromatography-mass spectrometry (LC-MS)	—

Secondary

Measure	Time frame
Trough plasma level of rivaroxaban (Cmin), peak plasma level of rivaroxaban (Cmax), T1/2 and area under the concentration curve (AUC), accuracy of plasma level detection of anti-Xa level assay compared to LC-MS	—

Countries

Netherlands

Outcome results