Permanent discontinuation of the study medication

Consideration may be given to permanent discontinuation in the following situations:

  1. Life-threatening or intracranial bleeding,
  2. requirement for long-term anticoagulant therapy,
  3. requirement for long-term dual anti-platelet therapy,
  4. 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),
  5. if the participant undergoes kidney transplant surgery,
  6. pregnancy,
  7. 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
  8. 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.