check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

20031

ClinicalTrials.gov Identifier:

NCT03563937

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with Factor Xa non-vitamin-K oral anticoagulants (NOACs) vs. Phenprocoumon

Trial purpose

Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.
The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).
    - Age of at least 18 years at index date.
    - Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
    - A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
  • - A verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (VTE).
    - A claim for hip or knee replacement surgery in the 60 days prior to or on the index date.
    - A prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date.
    - A prescription of warfarin or dabigatran in the baseline period or on the index date.
    - A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period.
    - Patients receiving an initial dose of rivaroxaban 10 mg/ 2.5 mg or edoxaban 15 mg (these dosages are not indicated for the treatment of NVAF).

Trial summary

Enrollment Goal
64920
Trial Dates
June 2018 - December 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Germany

Primary Outcome

  • Risk of Ischemic stroke (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint) and severe IS in patients with NVAF and renal impairment determined by inpatient claims based diagnoses
    Severe IS will be defined according to an approach proposed by Schubert et al. as hospitalization with a primary hospital discharge diagnosis of IS in combination with an OPS (Operationen und Prozedurenschlüssel) code indicating one of the following: intubation, mechanical ventilation or percutaneous endoscopic gastronomy
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Healthcare resource consumption in patients with non-valvular atrial fibrillation (NVAF) and renal impairment determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Overall costs in patients with renal impairment determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017

Secondary Outcome

  • Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses
    Fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Risk of recurrent hospitalizations (in general and for IS/SE)
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Risk of Kidney failure determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Risk of treatment discontinuation in patients with NVAF (overall population as well as patients with renal impairment) determined by pharmacy claims
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017
  • Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses
    date_rangeTime Frame:
    Retrospective analysis from January 2012 - December 2017

Trial design

Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with Factor Xa non-vitamin-K oral anticoagulants (NOACs) vs. Phenprocoumon
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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