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

NCT03563937 | Completed

• 1 other identifier: 20031
• Study Type: observational
• Target: 64,920
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  Retrospective analysis from January 2012 - December 2017

• Overall costs in patients with renal impairment determined by inpatient claims based diagnoses

  Retrospective analysis from January 2012 - December 2017

• Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses

  Retrospective analysis from January 2012 - December 2017

Secondary Outcomes (6)

• Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses

  Retrospective analysis from January 2012 - December 2017

• Risk of recurrent hospitalizations (in general and for IS/SE)

  Retrospective analysis from January 2012 - December 2017

• Risk of Kidney failure determined by inpatient claims based diagnoses

  Retrospective analysis from January 2012 - December 2017

• Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses

  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

  Retrospective analysis from January 2012 - December 2017

Study Arms (4)

Phenprocoumon

Patients with NVAF who initiated the treatment of Phenprocoumon.

Drug: Phenprocoumon

Apixaban

Patients with NVAF who initiated the treatment of Apixaban.

Drug: Apixaban

Rivaroxaban (Xarelto, BAY59-7939)

Patients with NVAF who initiated the treatment of Rivaroxaban.

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Edoxaban

Patients with NVAF who initiated the treatment of Edoxaban.

Drug: Edoxaban

Interventions

Phenprocoumon DRUG

Follow the physician's prescription.

Phenprocoumon

Apixaban DRUG

2.5 mg or 5 mg, twice daily

Apixaban

Rivaroxaban (Xarelto, BAY59-7939) DRUG

15 mg or 20 mg, once daily

Rivaroxaban (Xarelto, BAY59-7939)

Edoxaban DRUG

30 mg or 60 mg, once daily

Edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Many Locations

Multiple Locations, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Phenprocoumon; apixaban; Rivaroxaban; edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 20, 2018
• Study Start: June 15, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

DE (1)