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Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon (ReLoaDeD)

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ClinicalTrials.gov Identifier: NCT03563937
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

June 11, 2018
June 20, 2018
October 17, 2018
June 15, 2018
December 31, 2018   (Final data collection date for primary outcome measure)
  • 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 [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
    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
  • Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
Same as current
Complete list of historical versions of study NCT03563937 on ClinicalTrials.gov Archive Site
  • Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
    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.
  • Risk of recurrent hospitalizations (in general and for IS/SE) [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  • Risk of Kidney failure determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  • Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses [ Time 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 [ Time 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 [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
Same as current
Not Provided
Not Provided
 
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
The source population of this study will include all insured members of approximately 64 German statutory health insurances (SHIs) contributing data to the InGef database.
Atrial Fibrillation
  • Drug: Phenprocoumon
    Follow the physician's prescription.
  • Drug: Apixaban
    2.5 mg or 5 mg, twice daily
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    15 mg or 20 mg, once daily
  • Drug: Edoxaban
    30 mg or 60 mg, once daily
  • Phenprocoumon
    Patients with NVAF who initiated the treatment of Phenprocoumon.
    Intervention: Drug: Phenprocoumon
  • Apixaban
    Patients with NVAF who initiated the treatment of Apixaban.
    Intervention: Drug: Apixaban
  • Rivaroxaban (Xarelto, BAY59-7939)
    Patients with NVAF who initiated the treatment of Rivaroxaban.
    Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
  • Edoxaban
    Patients with NVAF who initiated the treatment of Edoxaban.
    Intervention: Drug: Edoxaban
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90000
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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 heparin or fondaparinux 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT03563937
20031
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bayer
Bayer
Janssen Research & Development, LLC
Not Provided
Bayer
October 2018