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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 : April 20, 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
Venous Thrombosis Pulmonary Embolism Atrial Fibrillation Acute Coronary Syndrome Drug: Rivaroxaban (Xarelto, Bay59-7939) Drug: Warfarin Drug: Antiplatelet drugs

Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 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

MedlinePlus related topics: Blood Thinners
Drug Information available for: Rivaroxaban
U.S. FDA Resources

Group/Cohort Intervention/treatment
Rivaroxaban / Cohort 1
Patients who have been prescribed Rivaroxaban for the first time
Drug: Rivaroxaban (Xarelto, Bay59-7939)

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

The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors (20 mg rivaroxaban [od], tablets).

The prevention of venous thromboembolism (VTE) in adult 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 adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid]).

Standard of care / Cohort 2
Patients who have been prescribed Standard of care for the first time
Drug: Warfarin
For VTE prevention, DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, warfarin.
Drug: Antiplatelet drugs
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



Primary Outcome Measures :
  1. 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 8 years ]
  2. Characteristics of rivaroxaban use in comparison with standard of care [ Time Frame: Up to 8 years ]
  3. Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care [ Time Frame: Up to 8 years ]

    Cases of intracranial haemorrhage will be identified in patients referred to a specialist or admitted to hospital that meet the criteria for one of the three following categories:

    • incident cases of intracerebral haemorrhage recorded following or in association with computed tomography, magnetic resonance imaging (MRI) or X-ray angiography, or an appropriate therapeutic procedure.
    • incident cases of subarachnoid haemorrhage recorded following computed tomography, MRI, Xray angiography or lumbar puncture, or an appropriate therapeutic procedure.
    • incident cases of epidural, dural, subdural and arachnoid haemorrhage recorded following computed tomography, MRI, X-ray angiography or lumbar puncture, or an appropriate therapeutic procedure.

  4. Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care [ Time Frame: Up to 8 years ]

    A patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding:

    • the specific site of bleeding originating in the upper or lower gastrointestinal tract or, more specifically, in the oesophagus, stomach, duodenum, jejunum, ileum, colon or rectum
    • for upper gastrointestinal bleeding, the lesion type being erosion, gastritis, duodenitis or peptic (gastric or duodenal) ulcer
    • the lesion type being NOT related to cancer
    • the patient having been referred to a specialist or admitted to hospital.

  5. Safety: occurrence urogenital bleeding leading to hospitalization [ Time Frame: Up to 8 years ]

    A patient will have to meet both of the following criteria to be considered a case of urogenital bleeding:

    • the specific site of bleeding originating in the urogenital tract.
    • the patient having been referred to a specialist or admitted to hospital.


Secondary Outcome Measures :
  1. Safety: occurrence of bleeding events leading to hospitalization not specified as primary safety outcomes ("other bleeding") in individuals receiving rivaroxaban, in comparison with those receiving current standard of care [ Time Frame: Up to 8 years ]

    A patient will have to meet the following criteria to be considered a case of "other bleeding":

    • admitted to hospital with a bleeding event occurring before hospitalization (i.e. excluding inhospital bleeding events).


  2. Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care. [ Time Frame: Up to 8 years ]

    A patient will have to meet all of the following criteria to be considered a case of non-infective liver disease:

    • an increase of more than three times the upper limit of the normal range in alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or a combined increase in ALT, AST or alkaline phosphatase and total bilirubin, provided one of them is twice the upper limit of the respective normal range.
    • the patient having been referred to a specialist or admitted to hospital.
    • free of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease and alcoholism.

  3. Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care. [ Time Frame: Up to 8 years ]
    A patient will have to meet the following criteria to be considered a case of DVT or PE: the patient having been admitted to hospital with a diagnosis of DVT or PE

  4. Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care [ Time Frame: Up to 8 years ]
    A patient will have to meet the following criteria to be considered a case of ischaemic stroke: the patient having been admitted to hospital with a diagnosis of ischaemic stroke.

  5. Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care [ Time Frame: Up to 8 years ]
    A patient will have to meet the following criteria to be considered a case of MI: the patient having been admitted to hospital with a diagnosis of MI

  6. All-cause mortality as well as cause-specific mortality [ Time Frame: Up to 8 years ]

    For ascertainment of mortality automatic computer searches will be performed, based on:

    • Read Codes
    • Death certification incorporated in The Health Information Network (THIN)
    • Registration status of the patient recorded in THIN



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients aged 2 years and above who have been enrolled with a primary care physician for at least 1 year and had their first prescription recorded in the THIN database at least 1 year ago
Criteria

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 prescribed their index drug prior to the enrolment period or who qualify as members of both cohorts on the same day, will be excluded


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: April 20, 2018
Last Verified: March 2018

Keywords provided by Bayer:
Rivaroxaban
Stroke Prevention in Atrial Fibrillation,
Anticoagulants
Hematologic Agents
Therapeutic Uses
Observational
Venous Thromboembolism
Secondary Prevention of Acute Coronary Syndrome
Intracranial Hemorrhages
Gastrointestinal Hemorrhage,

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Acute Coronary Syndrome
Embolism
Pulmonary Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Myocardial Ischemia
Lung Diseases
Respiratory Tract Diseases
Warfarin
Rivaroxaban
Platelet Aggregation Inhibitors
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action