Study Completed

Atrial Fibrillation (Prevention of Stroke)

Bayer Identifier:

18073

ClinicalTrials.gov Identifier:

NCT02485873

EudraCT Number:

Not Available

EU CT Number:

Not Available

Real-Life Evidence on Stroke Prevention in SPAF

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial summary

Enrollment Goal

8607

Trial Dates

May 2015 - August 2015

Phase

N/A

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Germany

Primary Outcome

Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI)
Composite cardiovascular endpoint
Time Frame:
Within 1 year after treatment start
Safety Issue:
No

Secondary Outcome

Time to first occurrence of IS
Single cardiovascular event
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Time to first occurrence of TIA
Single cardiovascular event
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Time to first occurrence of IH
Single cardiovascular event
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
Single cardiovascular event
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Time to first occurrence of MI
Single cardiovascular event
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Incidence density in study population of IS
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Incidence density in study population of TIA
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Incidence density in study population of IH
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Incidence density in study population of MI
Time Frame:
Within 1 year after treatment start
Safety Issue:
No
Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI
Time Frame:
Within 1 year after treatment start
Safety Issue:
No

Trial design

REal-LIfe Evidence on Stroke Prevention in patients with Atrial Fibrillation

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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