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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

NCT ID: NCT03563937

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64920 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Phenprocoumon

Patients with NVAF who initiated the treatment of Phenprocoumon.

Phenprocoumon

Intervention Type DRUG

Follow the physician's prescription.

Apixaban

Patients with NVAF who initiated the treatment of Apixaban.

Apixaban

Intervention Type DRUG

2.5 mg or 5 mg, twice daily

Rivaroxaban (Xarelto, BAY59-7939)

Patients with NVAF who initiated the treatment of Rivaroxaban.

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

15 mg or 20 mg, once daily

Edoxaban

Patients with NVAF who initiated the treatment of Edoxaban.

Edoxaban

Intervention Type DRUG

30 mg or 60 mg, once daily

Interventions

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Phenprocoumon

Follow the physician's prescription.

Intervention Type DRUG

Apixaban

2.5 mg or 5 mg, twice daily

Intervention Type DRUG

Rivaroxaban (Xarelto, BAY59-7939)

15 mg or 20 mg, once daily

Intervention Type DRUG

Edoxaban

30 mg or 60 mg, once daily

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , Germany

Site Status

Countries

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Germany

Related Links

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https://clinicaltrials.bayer.com/

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

Other Identifiers

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20031

Identifier Type: -

Identifier Source: org_study_id