Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

Completed

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

• Registration Number: NCT01947985
• 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 Acenocoumarol 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: 2012-02-01
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Primary Completion: 2018-12-31
• Study Completion: 2020-09-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208958

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

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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 will be excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxoban	Rivaroxoban (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 at index date 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 Renal disease based on in- and outpatient diagnoses Hospital admissions for bleeding Healthcare utilization (e.g. number of hospital admissions). Smoking status Body mass index (BMI)
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 patients admitted to the hospital 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 Potential cases will be identified by hospital discharge diagnoses
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: The specific site of bleeding originating 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.; The lesion type being NOT related to cancer. Cases will be identified by hospital discharge diagnoses (ICD-9-CM).
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 be admitted to the hospital for urogenital bleeding, i.e. the specific site of bleeding originating in the urogenital tract.; Cases will be identified by hospital discharge diagnoses (ICD-9-CM).

Secondary Outcome Measures

Name	Time	Method
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": Admitted to hospital with a bleeding event occurring before hospitalization (i.e. excluding inhospital bleeding events).; Cases will be identified by hospital discharge diagnoses (ICD-9-CM).
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 both of the following criteria to be considered a case of non-infective liver disease: The patient having been admitted to hospital with acute liver injury. Free of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease and alcoholism.
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: The patient having been admitted to hospital with a diagnosis of DVT or PE or having a DVT or PE diagnosis documented in the general practitioner database.
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: the patient having been admitted to hospital with a diagnosis of ischaemic stroke.
All-cause mortality as well as cause-specific mortality	up to 8 years	Date of death as registered in the different databases (GP, pharmacy, hospital deaths) and confirmed through linkage with the Dutch central bureau of genealogy
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 the following criteria to be considered a case of MI: the patient having been admitted to hospital with a diagnosis of MI.