Clinical trial NCT02468102: Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
Official title: A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Venous Thrombosis
Pulmonary Embolism
Atrial Fibrillation
Keywords: Rivaroxaban
Venous Thrombosis/Pulmonary Embolism
Stroke Prevention in Atrial Fibrillation
Anticoagulants
Hematologic Agents
Therapeutic Uses
Observational
Pulmonary Embolism
Venous Thrombosis
Venous Thromboembolism
Intracranial Hemorrhages
Gastrointestinal Hemorrhage
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2015-06-10
Enrollment: 99999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Sweden: The study population will be identified using data from the Swedish national health registers that are maintained by the national Board of Health and Welfare.

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: 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
timeFrame: up to 4 years
measure: 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
timeFrame: up to 5 years
Secondary outcomes:
measure: 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.
timeFrame: at 5 years
measure: Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.
timeFrame: at 5 years
measure: Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.
timeFrame: at 5 years
measure: All-cause mortality as well as cause-specific mortality.
timeFrame: at 5 years
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: