Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01947985
First received: September 11, 2013
Last updated: June 27, 2014
Last verified: June 2014

September 11, 2013
June 27, 2014
February 2012
December 2018   (final data collection date for primary outcome measure)
  • Major bleedings: Intracranial haemorrhage, Gastrointestinal bleeding and Urogenital bleeding [ Time Frame: The two cohorts will be followed up from the index date until 12 months after the end of the extended enrollment period for potential outcomes ] [ Designated as safety issue: Yes ]
    Crude incidence rates will be estimated for each of the three primary adverse outcomes in both cohorts. Age- and sex-adjusted rate ratios with 95% CIs will be estimated for each of the three primary adverse outcomes comparing Rivaroxaban with VKA using Poisson regression analysis.
  • Drug utilization pattern [ Time Frame: The two cohorts will be followed up from the index date until 12 months after the end of the extended enrollment period for potential outcomes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01947985 on ClinicalTrials.gov Archive Site
  • Non-infective liver disease [ Time Frame: The two cohorts will be followed up from the index date until 12 months after the end of the extended enrolment period for potential outcomes. ] [ Designated as safety issue: Yes ]
  • Effectiveness outcomes: Deep vein thrombosis and Pulmonary embolism, Ischaemic stroke, Myocardial infarction, Death [ Time Frame: The two cohorts will be followed up from the index date until 12 months after the end of the extended enrolment period for potential outcomes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)
A Proposed Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the Netherlands.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All male and female patient aged 2 to 89 years who have been enrolled in the database (PHARMO) for at least 1 year and who had their first dispensed prescription recorded in the database at least 1 year ago will be included.

Pulmonary Embolism
  • Drug: Rivaroxoban (Xarelto, Bay59-7939)
    Patients who have been prescribed Rivaroxaban for the first time, divided in two subgroups: Naïve and Non Naïve. The Non Naïve are also divided in two subgroups: Recent switchers and Distant switchers.
  • Drug: Acenocoumarol
    Patients who have been prescribed Acenocoumarol for the first time, divided in two subgroups: Naïve and Non Naïve. The Non Naïve are also divided in two subgroups: Recent switchers and Distant switchers.
  • Rivaroxoban
    Intervention: Drug: Rivaroxoban (Xarelto, Bay59-7939)
  • Acenocoumarol
    Intervention: Drug: Acenocoumarol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
December 2019
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Patients between 2 and 89 years, who have been prescribed for the first time either Rivaroxaban or Acenocoumarol.

Exclusion Criteria:

-

Both
2 Years to 89 Years
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Netherlands
 
NCT01947985
16646
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP