check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18735

ClinicalTrials.gov Identifier:

NCT02960880

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists

Trial purpose

The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
    - At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
    - Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
    - ≥ 18 years of age

  • - Patients with valvular AF [4 quarters prior to the index date]
    - Pregnancy [4 quarters prior to index date]
    - Malignant cancers [4 quarters prior to the index date or “condition after”]
    - Transient cause of AF [4 quarters prior to index date]
    - Patients with VTE (pulmonary embolism or DVT) [60 days before index]
    - Patients with major surgery defined as hip or knee replacement [60 days before index]
    - Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date [4 quarters prior to index date]
    - Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
    - For sensitivity analysis : Patient with any of the events defined in the combined endpoints [4 quarters prior to index date or “condition after”
    - Patients with dialysis [4 quarters prior to index date]

Trial summary

Enrollment Goal
99999
Trial Dates
October 2016 - December 2016
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, Germany

Primary Outcome

  • Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists
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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