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

Completed

• Conditions: Pulmonary Embolism; Venous Thrombosis; Atrial Fibrillation; Acute Coronary Syndrome
• Interventions: Drug: Rivaroxaban (Xarelto, Bay59-7939); Drug: Warfarin; Drug: Antiplatelet drugs

• Registration Number: NCT01947998
• 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 Warfarin 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: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50299

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

Exclusion Criteria

• Patients who have any record of being prescribed their index drug prior to the enrolment period or who qualify as members of both cohorts on the same day, will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care / Cohort 2	Antiplatelet drugs	Patients who have been prescribed Standard of care for the first time
Rivaroxaban / Cohort 1	Rivaroxaban (Xarelto, Bay59-7939)	Patients who have been prescribed Rivaroxaban for the first time
Standard of care / Cohort 2	Warfarin	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
Characteristics of rivaroxaban use in comparison with standard of care	Up to 8 years
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 referred to a specialist or admitted to hospital that meet the criteria for one of the three following categories: * incident cases of intracerebral haemorrhage recorded following or in association with computed tomography, magnetic resonance imaging (MRI) or X-ray angiography, or an appropriate therapeutic procedure.; * incident cases of subarachnoid haemorrhage recorded following computed tomography, MRI, Xray angiography or lumbar puncture, or an appropriate therapeutic procedure.; * incident cases of epidural, dural, subdural and arachnoid haemorrhage recorded following computed tomography, MRI, X-ray angiography or lumbar puncture, or an appropriate therapeutic procedure.
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; * the patient having been referred to a specialist or admitted to hospital.
Safety: occurrence urogenital bleeding leading to hospitalization	Up to 8 years	A patient will have to meet both of the following criteria to be considered a case of urogenital bleeding: * the specific site of bleeding originating in the urogenital tract.; * the patient having been referred to a specialist or admitted to hospital.

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).
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: * an increase of more than three times the upper limit of the normal range in alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or a combined increase in ALT, AST or alkaline phosphatase and total bilirubin, provided one of them is twice the upper limit of the respective normal range.; * the patient having been referred to a specialist or admitted to hospital.; * 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
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.
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
All-cause mortality as well as cause-specific mortality	Up to 8 years	For ascertainment of mortality automatic computer searches will be performed, based on: * Read Codes; * Death certification incorporated in The Health Information Network (THIN); * Registration status of the patient recorded in THIN