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Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists

NCT ID: NCT02960880

Last Updated: 2017-12-26

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

99999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-15

Study Completion Date

2016-12-31

Brief Summary

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The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Rivaroxaban, Phenprocoumon, retrospective cohort study, Non-Valvular Atrial fibrillation, NVAF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rivaroxaban

NVAF patients who were newly initiated on Rivaroxaban for stroke prevention

Rivaroxaban (Xarelto, BAY597939)

Intervention Type DRUG

15mg, 20mg

Phenprocoumon

NVAF patients who were newly initiated on Phenprocoumon for stroke prevention

Phenprocoumon (branded and generics)

Intervention Type DRUG

Individually adjusted dose

Interventions

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Rivaroxaban (Xarelto, BAY597939)

15mg, 20mg

Intervention Type DRUG

Phenprocoumon (branded and generics)

Individually adjusted dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
* At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
* Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
* ≥ 18 years of age

Exclusion Criteria

* Patients with valvular AF \[4 quarters prior to the index date\]
* Pregnancy \[4 quarters prior to index date\]
* Malignant cancers \[4 quarters prior to the index date or "condition after"\]
* Transient cause of AF \[4 quarters prior to index date\]
* Patients with VTE (pulmonary embolism or DVT) \[60 days before index\]
* Patients with major surgery defined as hip or knee replacement \[60 days before index\]
* Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date \[4 quarters prior to index date\]
* Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
* For sensitivity analysis : Patient with any of the events defined in the combined endpoints \[4 quarters prior to index date or "condition after"
* Patients with dialysis \[4 quarters prior to index date\]
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

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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18735

Identifier Type: -

Identifier Source: org_study_id