check_circleStudy Completed

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

Bayer Identifier:

16159

ClinicalTrials.gov Identifier:

NCT01947959

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study of Rivaroxaban use and potential adverse outcomes in routine clinical practice (Germany)

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
Phenprocoumon 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

Trial summary

Enrollment Goal
665533
Trial Dates
December 2011 - September 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

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 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 Comorbidity based on inpatient and outpatient diagnoses Renal disease based on in- and outpatient diagnoses Healthcare utilization (e.g. number of hospital admissions).
    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 hospitalized patients with a discharge diagnosis of intracranial haemorrhage 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
    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: A hospital admission with a discharge diagnosis of gastrointestinal bleeding, i.e. a bleeding riginating 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.
    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 meet the following criteria to be considered a case of urogenital bleeding: A hospital admission with a discharge diagnosis of urogenital bleeding.
    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”: A hospital admission with a discharge diagnosis of "other bleeding"
    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 all of the following criteria to be considered a case of non-infective liver disease: A hospital admission with a discharge diagnosis of acute liver injury. No diagnosis of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease, or 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: A hospital admission with a discharge diagnosis of DVT or PE, or an ambulatory diagnosis of DVT with a dispensation of another antithrombotic agent
    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: A hospital admission with a main discharge 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 all of the following criteria to be considered a case of acute myocardial infarction: A hospital admission with a main discharge diagnosis of acute MI
    date_rangeTime Frame:
    up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • All-cause mortality as well as cause-specific mortality
    Deaths can be identified from core data and hospital data
    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 Germany
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A