Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)

Recruiting

Phase N/A Results N/A

Trial Description

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Conditions

Interventions

  • Standard of care Drug
    Intervention Desc: For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.
    ARM 1: Kind: Experimental
    Label: Standard of care
    Description: Patients who have been prescribed Standard of care for the first time
  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: The treatment of DVT or PE, and prevention of recurrent DVT and PE in adult patients (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets). The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors (20 mg rivaroxaban [od], tablets). The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery). Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid]).
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: Patients who have been prescribed Rivaroxaban for the first time

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

All patients aged 2 years and above who have been enrolled in German Pharmacoepidemiological Research Database (GePaRD) for at least one year.

Outcomes

Type Measure Time Frame Safety Issue
Primary Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time up to 8 years No
Primary Characteristics of rivaroxaban use in comparison with standard of care up to 8 years No
Primary Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care up to 8 years Yes
Primary Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care up to 8 years Yes
Primary Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care up to 8 years Yes
Secondary Safety: occurrence of bleeding events leading to hospitalization not specified as primary safety outcomes ("other bleeding") in individuals receiving rivaroxaban, in comparison with those receiving current standard of care up to 8 years Yes
Secondary Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care up to 8 years Yes
Secondary Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care up to 8 years Yes
Secondary Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care up to 8 years Yes
Secondary Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care up to 8 years Yes
Secondary All-cause mortality as well as cause-specific mortality up to 8 years Yes

Sponsors