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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01947985
First received: September 11, 2013
Last updated: July 29, 2014
Last verified: July 2014
  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.


Condition Intervention
Pulmonary Embolism
Drug: Rivaroxoban (Xarelto, Bay59-7939)
Drug: Acenocoumarol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Proposed Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the Netherlands.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20000
Study Start Date: February 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxoban 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.
Acenocoumarol 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.

  Eligibility

Ages Eligible for Study:   2 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947985

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

Locations
Netherlands
Recruiting
Many Locations, Netherlands
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01947985     History of Changes
Other Study ID Numbers: 16646
Study First Received: September 11, 2013
Last Updated: July 29, 2014
Health Authority: Netherlands: Healthcare Inspectorate (Inspectie voor de Gezondheidszorg)

Keywords provided by Bayer:
Rivaroxaban,
Pulmonary Embolism,
Venous Thrombosis,
Venous Thromboembolism,
Acute Coronary Syndrome,
Intracranial Hemorrhages,
Gastrointestinal Hemorrhage,
Acenocoumarol

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Acenocoumarol
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014