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

This study is currently recruiting participants.
Verified November 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02468102
First Posted: June 10, 2015
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer
  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 standard of care for the first time.

The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Condition Intervention
Acute Coronary Syndrome Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Standard of care drugs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: up to 4 years ]
    The following data will be collected and assessed at 2 and 4 years after rivaroxaban market authorization: • age and sex distribution at index date • dose of rivaroxaban at index date • diagnosis associated with the prescribing of the index drug • use of specific prescribed medications confirming ACS indication • use of other prescribed medications • comorbidity based on diagnoses • renal impairment • healthcare utilization (e.g. outpatient visits and hospital admissions)

  • 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 [ Time Frame: up to 5 years ]

    The two cohorts will be followed up from the index date until 12 months after the end of the enrolment period for potential outcomes For descriptive purposes, annualized crude incidence rates of the major bleeding events will be calculated, accompanied by 95% confidence intervals.

    For evaluation of safety and effectiveness outcome events, Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.



Secondary Outcome Measures:
  • 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. [ Time Frame: at 5 years ]
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.

  • Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care. [ Time Frame: at 5 years ]
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.

  • Outcomes related to effectiveness (ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care. [ Time Frame: at 5 years ]
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.

  • All-cause mortality as well as cause-specific mortality. [ Time Frame: at 5 years ]
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.


Estimated Enrollment: 40000
Actual Study Start Date: June 1, 2015
Estimated Study Completion Date: April 1, 2020
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxaban / Cohort 1
Patients who have filled a prescription for rivaroxaban in any pharmacy in Sweden during the study period.
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).

Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors, prior stroke or transient ischaemic attack (20 mg rivaroxaban [od], tablets).

Prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).

Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid]).

Standard of care drugs / Cohort 2
Patients who have filled a prescription for standard of care drugs (warfarin, aspirin, clopidogrel, ticlopidine, prasugrel or ticagrelor) in any pharmacy in Sweden during the study period.
Drug: Standard of care drugs
For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of Sweden: The study population will be identified using data from the Swedish national health registers that are maintained by the national Board of Health and Welfare.
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

  Contacts and Locations
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): NCT02468102


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
Sweden
Many Locations Recruiting
Many Locations, Sweden
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02468102     History of Changes
Other Study ID Numbers: 17543
XA1405SE ( Other Identifier: Company internal )
First Submitted: June 8, 2015
First Posted: June 10, 2015
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Bayer:
Rivaroxaban
Venous Thrombosis/Pulmonary Embolism
Stroke Prevention in Atrial Fibrillation
Anticoagulants
Hematologic Agents
Therapeutic Uses
Observational
Pulmonary Embolism
Venous Thrombosis
Venous Thromboembolism
Intracranial Hemorrhages
Gastrointestinal Hemorrhage

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Rivaroxaban
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors