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

NCT01947985 | Completed

• 2 other identifiers: 16646EUPAS11141
• Study Type: observational
• Target: 208,958
• 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 Acenocoumarol 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

  Age and sex distribution at index date Proportion of patients defined as naïve, non-naïve, recent switchers and distant switchers Type and estimated duration of other anticoagulant use among the non-naïve group and for all patients Number of pregnancies and pregnancy outcomes' Use of specific prescribed medications confirming ACS indication Use of other prescribed medications Renal disease based on in- and outpatient diagnoses Hospital admissions for bleeding Healthcare utilization (e.g. number of hospital admissions). Smoking status Body mass index (BMI)

  up to 8 years

• Characteristics of rivaroxaban use in comparison with standard of care

  Estimated dose of index drug at index date and estimated duration of treatment Where available, the diagnosis associated with the prescribing of the index drug (where not available, estimated dose and duration of index drug will be used as a proxy for the associated diagnosis among rivaroxaban users) Dispensed amount (can be used to estimate duration of treatment)

  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 admitted to the hospital that meet the criteria for one of the three following categories: Incident cases of intracerebral haemorrhage Incident cases of subarachnoid haemorrhage incident cases of epidural, dural, subdural and arachnoid haemorrhage Potential cases will be identified by hospital discharge diagnoses

  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. Cases will be identified by hospital discharge diagnoses (ICD-9-CM).

  up to 8 years

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

  A patient will have to be admitted to the hospital for urogenital bleeding, i.e. the specific site of bleeding originating in the urogenital tract. Cases will be identified by hospital discharge diagnoses (ICD-9-CM).

  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)

Rivaroxoban

Patients who have been prescribed Rivaroxaban for the first time

Drug: Rivaroxoban (Xarelto, Bay59-7939)

Standard of care

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

Drug: Standard of care

Interventions

Rivaroxoban (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 \[bid\]).

Rivaroxoban

Standard of care DRUG

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.

Standard of care

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 registered in the PHARMO database for at least 1 year before the index date.

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 dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day will be excluded

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Netherlands

Location

Related Links

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MeSH Terms

Conditions

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

Interventions

Rivaroxaban; Standard of Care

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; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

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: February 1, 2012
• Primary Completion: December 31, 2018
• Study Completion: September 30, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

NL (1)