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Completed

NCT Number: NCT01947998

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

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.

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Key information

Conditions

Venous Thrombosis Acute Coronary Syndrome Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Digestive System Diseases Embolism Embolism and Thrombosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Heart Diseases Hemorrhage Intracranial Hemorrhages Lung Diseases Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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]).

Warfarin

Drug

For VTE prevention, DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, warfarin.

antiplatelet drugs

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the United Kingdom.

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2013
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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