check_circleStudy Completed

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

Bayer Identifier:

16646

ClinicalTrials.gov Identifier:

NCT01947985

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice (Netherlands)

Trial 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 Acenocoumarol for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Key Participants Requirements

Sex

Both

Age

2 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
208958
Trial Dates
February 2012 - September 2020
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Netherlands

Primary Outcome

  • 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)
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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).
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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).
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 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
    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). Cases will be identified by hospital discharge diagnoses (ICD-9-CM).
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care
    A patient will have to meet both of the following criteria to be considered a case of non-infective liver disease: The patient having been admitted to hospital with acute liver injury. Free of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease and alcoholism.
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care
    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 or having a DVT or PE diagnosis documented in the general practitioner database.
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care
    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.
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care
    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.
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • All-cause mortality as well as cause-specific mortality
    Date of death as registered in the different databases (GP, pharmacy, hospital deaths) and confirmed through linkage with the Dutch central bureau of genealogy
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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