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

Completed

• Conditions: Venous Thrombosis; Acute Coronary Syndrome; Pulmonary Embolism; Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Standard of care drugs

• Registration Number: NCT02468102
• 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 standard of care 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 First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Study Start: 2015-06-15
• 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: 99999

Inclusion Criteria

• All male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in Sweden, between December 9, 2011 and December 31, 2018

Read More

Exclusion Criteria

• For the AF and DVT/PE treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between July 1, 2005 and December 9, 2011 will be excluded

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban / Cohort 1	Rivaroxaban (Xarelto, BAY59-7939)	Patients who have filled a prescription for rivaroxaban in any pharmacy in Sweden during the study period.
Standard of care drugs / Cohort 2	Standard of care drugs	Patients who have filled a prescription for standard of care drugs (warfarin, aspirin, clopidogrel, ticlopidine, prasugrel or ticagrelor) in any pharmacy in Sweden during the study period.

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 4 years	The following data will be collected and assessed at 2 and 4 years after rivaroxaban market authorization: • age and sex distribution at index date • dose of rivaroxaban at index date • diagnosis associated with the prescribing of the index drug • use of specific prescribed medications confirming ACS indication • use of other prescribed medications • comorbidity based on diagnoses • renal impairment • healthcare utilization (e.g. outpatient visits and hospital admissions)
Safety and effectiveness: occurrence of hospitalization for a) intracranial haemorrhage, (b) gastrointestinal bleeding, (c) urogenital bleeding among users of rivaroxaban in comparison with individuals receiving current standard of care	up to 5 years	The two cohorts will be followed up from the index date until 12 months after the end of the enrolment period for potential outcomes For descriptive purposes, annualized crude incidence rates of the major bleeding events will be calculated, accompanied by 95% confidence intervals.; For evaluation of safety and effectiveness outcome events, Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.

Secondary Outcome Measures

Name	Time	Method
Occurrence of hospitalization for bleeding events not specified as primary safety outcomes ("other bleeding", secondary safety outcome) in individuals receiving rivaroxaban, in comparison with those receiving current standard of care.	at 5 years	Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.	at 5 years	Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.	at 5 years	Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
All-cause mortality as well as cause-specific mortality.	at 5 years	Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.

Trial Locations

Locations (1)

Many Locations; 🇸🇪 Multiple Locations, Sweden