Trial Condition(s):

Venous thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome

Study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice (Netherlands)

Bayer Identifier:

16646

ClinicalTrials.gov Identifier:

NCT01947985

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
208958
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Netherlands

Status
Completed
 

Trial Design