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

Completed

• Conditions: Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Acute Coronary Syndrome
• Interventions: Drug: Rivaroxaban (Xarelto, Bay59-7939); Drug: Standard of care

• Registration Number: NCT01947959
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-22
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 665533

Inclusion Criteria

• All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017

Read More

Exclusion Criteria

• Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, Bay59-7939)	Patients who have been prescribed Rivaroxaban for the first time
Standard of care	Standard of care	Patients who have been prescribed Standard of care for the first time

Primary Outcome Measures

Name	Time	Method
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	Age and sex distribution Proportion of patients defined as naïve, non-naïve, recent switchers and distant switchers Type and estimated duration of other anticoagulant use among the non-naïve group and for all patients Number of pregnancies and pregnancy outcomes' Use of specific prescribed medications confirming ACS indication Use of other prescribed medications Comorbidity based on inpatient and outpatient diagnoses Renal disease based on in- and outpatient diagnoses Healthcare utilization (e.g. number of hospital admissions).
Characteristics of rivaroxaban use in comparison with standard of care	up to 8 years	Estimated dose of index drug at index date and estimated duration of treatment Where available, the diagnosis associated with the prescribing of the index drug (where not available, estimated dose and duration of index drug will be used as a proxy for the associated diagnosis among rivaroxaban users) Dispensed amount (can be used to estimate duration of treatment)
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	Cases of intracranial haemorrhage will be identified in hospitalized patients with a discharge diagnosis of intracranial haemorrhage that meet the criteria for one of the three following categories: Incident cases of intracerebral haemorrhage Incident cases of subarachnoid haemorrhage Incident cases of epidural, dural, subdural and arachnoid haemorrhage
Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of urogenital bleeding: A hospital admission with a discharge diagnosis of urogenital bleeding.
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	A patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding: A hospital admission with a discharge diagnosis of gastrointestinal bleeding, i.e. a bleeding riginating in the upper or lower gastrointestinal tract or, more specifically, in the oesophagus, stomach, duodenum, jejunum, ileum, colon or rectum. For upper gastrointestinal bleeding: the lesion type being erosion, gastritis, duodenitis or peptic (gastric or duodenal) ulcer.

Secondary Outcome Measures

Name	Time	Method
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	A patient will have to meet the following criteria to be considered a case of DVT or PE: A hospital admission with a discharge diagnosis of DVT or PE, or an ambulatory diagnosis of DVT with a dispensation of another antithrombotic agent
Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of ischaemic stroke: A hospital admission with a main discharge diagnosis of ischaemic stroke.
Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet all of the following criteria to be considered a case of acute myocardial infarction: A hospital admission with a main discharge diagnosis of acute MI
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	A patient will have to meet all of the following criteria to be considered a case of non-infective liver disease: A hospital admission with a discharge diagnosis of acute liver injury. No diagnosis of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease, or alcoholism
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	A patient will have to meet the following criteria to be considered a case of "other bleeding": A hospital admission with a discharge diagnosis of "other bleeding"
All-cause mortality as well as cause-specific mortality	up to 8 years	Deaths can be identified from core data and hospital data