Consideration may be given to permanent discontinuation in the following situations:
- Life-threatening or intracranial bleeding,
- requirement for long-term anticoagulant therapy,
- requirement for long-term dual anti-platelet therapy,
- requirement for long-term treatment with medications that cannot be used in combination with rivaroxaban (e.g., strong inhibitors of combined CYP3A4 and P-glycoprotein: synthetic azole antimycotics, such ketoconazole, itraconazole, voriconazole, posaconazole; HIV-protease inhibitors, such as ritonavir; clarithromycin, erythromycin; strong inducers of CYP3A4: rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St John’s wort),
- if the participant undergoes kidney transplant surgery,
- the investigator/treating physician believes that for safety reasons (i.e., adverse event) it is in the best interest of the participant to stop the study medication, and
- at participant’s request.
All participants will remain in the trial even if they permanently discontinue the study medication. Permanent discontinuation of study treatment does not comprise study completion and is not a criterion for withdrawal from the study.