check_circleStudy Completed

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

Bayer Identifier:
16647
ClinicalTrials.gov Identifier:
NCT01947998
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice (UK)

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 Warfarin 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 prescribed their index drug prior to the enrolment period or who qualify as members of both cohorts on the same day, will be excluded

Trial summary

Enrollment Goal
50299
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, United Kingdom

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
    date_rangeTime Frame:
    Up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Characteristics of rivaroxaban use in comparison with standard of care
    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 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 8 years

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).
    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: • 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.
    date_rangeTime Frame:
    Up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 8 years
  • 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
  • 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
  • All-cause mortality as well as cause-specific mortality
    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
    date_rangeTime Frame:
    Up to 8 years

Trial design

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