check_circleStudy Completed

Acute Coronary Syndrome, Venous Thrombosis, Pulmonary embolism, Atrial fibrillation

Bayer Identifier:

17543

ClinicalTrials.gov Identifier:

NCT02468102

EudraCT Number:

Not Available

EU CT Number:

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

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 standard of care 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

NaN - N/A
  • - All male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in Sweden, between December 9, 2011 and December 31, 2018
  • - For the AF and DVT/PE treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between July 1, 2005 and December 9, 2011 will be excluded

Trial summary

Enrollment Goal
99999
Trial Dates
June 2015 - September 2020
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Sweden

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
    The following data will be collected and assessed at 2 and 4 years after rivaroxaban market authorization: • age and sex distribution at index date • dose of rivaroxaban at index date • diagnosis associated with the prescribing of the index drug • use of specific prescribed medications confirming ACS indication • use of other prescribed medications • comorbidity based on diagnoses • renal impairment • healthcare utilization (e.g. outpatient visits and hospital admissions)
    date_rangeTime Frame:
    up to 4 years
    enhanced_encryption
    Safety Issue:
    No
  • Safety and effectiveness: occurrence of hospitalization for a) intracranial haemorrhage, (b) gastrointestinal bleeding, (c) urogenital bleeding among users of rivaroxaban in comparison with individuals receiving current standard of care
    The two cohorts will be followed up from the index date until 12 months after the end of the enrolment period for potential outcomes For descriptive purposes, annualized crude incidence rates of the major bleeding events will be calculated, accompanied by 95% confidence intervals. For evaluation of safety and effectiveness outcome events, Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
    date_rangeTime Frame:
    up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Occurrence of hospitalization for bleeding events not specified as primary safety outcomes (“other bleeding”, secondary safety outcome) in individuals receiving rivaroxaban, in comparison with those receiving current standard of care.
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
    date_rangeTime Frame:
    at 5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
    date_rangeTime Frame:
    at 5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
    date_rangeTime Frame:
    at 5 years
    enhanced_encryption
    Safety Issue:
    No
  • All-cause mortality as well as cause-specific mortality.
    Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
    date_rangeTime Frame:
    at 5 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A pharmacoepidemiological study of rivaroxaban use and potential adverse outcomes in routine clinical practice in Sweden
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

Click here to find results for studies related to Bayer products