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

Atrial Fibrillation Clinical Trial

— ReLoaDeD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563937
• Other study ID #: 20031
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: November 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64920
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Phenprocoumon
Follow the physician's prescription.
• Apixaban
2.5 mg or 5 mg, twice daily
• Rivaroxaban (Xarelto, BAY59-7939)
15 mg or 20 mg, once daily
• Edoxaban
30 mg or 60 mg, once daily

Locations

Country	Name	City	State
Germany	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Overall costs in patients with renal impairment determined by inpatient claims based diagnoses		Retrospective analysis from January 2012 - December 2017
Primary	Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses		Retrospective analysis from January 2012 - December 2017
Secondary	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.	Retrospective analysis from January 2012 - December 2017
Secondary	Risk of recurrent hospitalizations (in general and for IS/SE)		Retrospective analysis from January 2012 - December 2017
Secondary	Risk of Kidney failure determined by inpatient claims based diagnoses		Retrospective analysis from January 2012 - December 2017
Secondary	Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses		Retrospective analysis from January 2012 - December 2017
Secondary	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
Secondary	Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses		Retrospective analysis from January 2012 - December 2017

External Links

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