check_circleStudy 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
  • - 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.

  • - 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
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Within 1 year after treatment start
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

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