Real-Life Evidence on Stroke Prevention in SPAF

NCT ID: NCT02485873

Last Updated: 2015-11-11

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

8607 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-09-30

Brief Summary

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To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting

Detailed Description

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Conditions

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Atrial Fibrillation (Prevention of Stroke)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rivaroxaban

Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

As prescribed by treating physicians

Vitamin K antagonists (VKA)

NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention

Vitamin K antagonists

Intervention Type DRUG

As prescribed by treating physicians

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

As prescribed by treating physicians

Intervention Type DRUG

Vitamin K antagonists

As prescribed by treating physicians

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window
* Diagnosis of NVAF on start date of study or anytime during 365 days before this date
* Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date)
* Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.

Exclusion Criteria

* Patients with valvular AF
* Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date
* Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period
* Prescriptions of \< 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

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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Many Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DBOX 2014/00799

Identifier Type: OTHER

Identifier Source: secondary_id

18073

Identifier Type: -

Identifier Source: org_study_id

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