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

NCT01947998 | Completed

• 2 other identifiers: 16647EUPAS11299
• Study Type: observational
• Target: 50,299
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Acute Coronary Syndrome

Keywords

Rivaroxaban; Stroke Prevention in Atrial Fibrillation; Anticoagulants; Hematologic Agents; Therapeutic Uses; Observational; Venous Thromboembolism; Secondary Prevention of Acute Coronary Syndrome; Intracranial Hemorrhages; Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (5)

• 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

  Up to 8 years

• Characteristics of rivaroxaban use in comparison with standard of care

  Up to 8 years

• Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care

  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.

  Up to 8 years

• Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care

  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.

  Up to 8 years

• Safety: occurrence urogenital bleeding leading to hospitalization

  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.

  Up to 8 years

Secondary Outcomes (6)

• 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

  Up to 8 years

• Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care.

  Up to 8 years

• Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.

  Up to 8 years

• Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care

  Up to 8 years

• Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care

  Up to 8 years

Study Arms (2)

Rivaroxaban / Cohort 1

Patients who have been prescribed Rivaroxaban for the first time

Drug: Rivaroxaban (Xarelto, Bay59-7939)

Standard of care / Cohort 2

Patients who have been prescribed Standard of care for the first time

Drug: Warfarin; Drug: Antiplatelet drugs

Interventions

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 \[bid\]).

Rivaroxaban / Cohort 1

Warfarin DRUG

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

Standard of care / Cohort 2

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

Standard of care / Cohort 2

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, United Kingdom

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Acute Coronary Syndrome; Venous Thromboembolism; Intracranial Hemorrhages; Gastrointestinal Hemorrhage

Interventions

Rivaroxaban; Warfarin; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Thromboembolism; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 23, 2013
• Study Start: December 22, 2011
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

GB (1)