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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Rivaroxaban (Xarelto, BAY59-7939) (Drug); Standard of care drugs (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Clinical Details

Official title: A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

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

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

Secondary outcome:

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.

Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.

Outcomes related to effectiveness (ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.

All-cause mortality as well as cause-specific mortality.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Sweden; Recruiting
Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: June 2015
Last updated: August 7, 2015

Page last updated: August 23, 2015

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