Clinical trial NCT01947985: Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)
Official title: A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the Netherlands.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Pulmonary Embolism
Atrial Fibrillation
Acute Coronary Syndrome
Keywords: Rivaroxaban
Stroke Prevention in Atrial Fibrillation
Anticoagulants
Hematologic Agents
Therapeutic Uses
Observational
Venous Thromboembolism
Secondary Prevention of Acute Coronary Syndrome
Intracranial Hemorrhages
Gastrointestinal Hemorrhage
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2013-09-23
Enrollment: 208958
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 2 years and above who have been registered in the PHARMO database for at least 1 year before the index date.

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.


Eligibility criteria: 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 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

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 8 years
measure: Characteristics of rivaroxaban use in comparison with standard of care
timeFrame: up to 8 years
measure: Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care
timeFrame: up to 8 years
measure: Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care
timeFrame: up to 8 years
measure: Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care
timeFrame: up to 8 years
Secondary outcomes:
measure: 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
timeFrame: up to 8 years
measure: Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care
timeFrame: up to 8 years
measure: Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care
timeFrame: up to 8 years
measure: Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care
timeFrame: up to 8 years
measure: Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care
timeFrame: up to 8 years
measure: All-cause mortality as well as cause-specific mortality
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Multiple Locations
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: