SYFeaff55c5032b43a7a1cce2d1ed2431f6Registry ID: 2024-519078-38-00|RecruitingPhase 4
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interventional
N/A
1 country
1
The main aim of this study is to assess the clinical outcomes of this patient population treated with long-term parenteral nutrition and taking rivaroxaban and to relate these clinical outcomes to the laboratory assessments. The primary outcomes are the clinical outcomes after at least one year an the (varibaility in the) laboratory concentrations
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2024
Actual (reported)i. Main study parameter/endpoint Clinical outcomes after one year, related to the laboratory levels per subject: * Efficacy: venous thromboembolism, cerebrovascular stroke * Safety: (major) bleeding cfr. ISTH criteria, mortality ii. Secondary study parameters/endpoints * Inter- and intraindividual variability of rivaroxaban absorption Laboratory outcomes: * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS Quality of life assessment * SF-36
iii. Other study parameters Baseline characteristics will be collected; * Age * Sex
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Formulated product
Xarelto 20 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Xarelto 20 mg film-coated tablets
Named ingredient: Rivaroxaban
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Amsterdam UMC Stichting
Amsterdam, 1105 AZ, Netherlands
Thijs van Haaps
First Submitted
October 15, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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