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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 October 2021 |
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Main ID: |
NCT02468102 |
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Date of registration:
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08/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
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Scientific title:
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A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden |
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Date of first enrolment:
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June 15, 2015 |
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Target sample size:
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99999 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02468102 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Embolism
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Atrial Fibrillation
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Acute Coronary Syndrome
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Venous Thrombosis
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Intervention(s)
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Drug: Standard of care drugs
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Drug: Rivaroxaban (Xarelto, BAY59-7939)
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Primary Outcome(s)
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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
[Time Frame: up to 4 years]
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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
[Time Frame: up to 5 years]
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Secondary Outcome(s)
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All-cause mortality as well as cause-specific mortality.
[Time Frame: at 5 years]
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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.
[Time Frame: at 5 years]
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Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.
[Time Frame: at 5 years]
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Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.
[Time Frame: at 5 years]
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Secondary ID(s)
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XA1405SE
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17543
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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