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

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ClinicalTrials.gov Identifier: NCT01947998
Recruitment Status : Recruiting
First Posted : September 23, 2013
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief 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 Warfarin for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Condition or disease Intervention/treatment
Pulmonary Embolism Drug: Rivaroxaban (Xarelto, Bay59-7939) Drug: Warfarin

Study Type : Observational
Estimated Enrollment : 20000 participants
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 United Kingdom.
Actual Study Start Date : December 22, 2011
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
Rivaroxaban
Drug: Rivaroxaban (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.
Group 2
Warfarin
Drug: Warfarin
Patients who have been prescribed Warfarin 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.



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]


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Ages Eligible for Study:   2 Years to 89 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 (GePaRD) for at least 1 year.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947998


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

Locations
United Kingdom
Recruiting
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01947998     History of Changes
Other Study ID Numbers: 16647
EUPAS11299 ( Registry Identifier: ENCEPP )
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action