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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 : July 23, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Phenprocoumon Drug: Apixaban Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Edoxaban

Study Type : Observational
Estimated Enrollment : 90000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Phenprocoumon
Patients with NVAF who initiated the treatment of Phenprocoumon.
Drug: Phenprocoumon
Follow the physician's prescription.

Apixaban
Patients with NVAF who initiated the treatment of Apixaban.
Drug: Apixaban
2.5 mg or 5 mg, twice daily

Rivaroxaban (Xarelto, BAY59-7939)
Patients with NVAF who initiated the treatment of Rivaroxaban.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg or 20 mg, once daily

Edoxaban
Patients with NVAF who initiated the treatment of Edoxaban.
Drug: Edoxaban
30 mg or 60 mg, once daily




Primary Outcome Measures :
  1. 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

  2. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. Risk of recurrent hospitalizations (in general and for IS/SE) [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  3. Risk of Kidney failure determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  4. Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563937


Locations
Germany
Many Locations
Multiple Locations, Germany
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03563937     History of Changes
Other Study ID Numbers: 20031
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Apixaban
Edoxaban
Anticoagulants
Phenprocoumon
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action