Real-Life Evidence on Stroke Prevention in SPAF

Completed

• Conditions: Atrial Fibrillation (Prevention of Stroke)
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Vitamin K antagonists

• Registration Number: NCT02485873
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8607

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention
Vitamin K antagonists (VKA)	Vitamin K antagonists	NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention

Primary Outcome Measures

Name	Time	Method
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)	Within 1 year after treatment start	Composite cardiovascular endpoint

Secondary Outcome Measures

Name	Time	Method
Time to first occurrence of IH	Within 1 year after treatment start	Single cardiovascular event
Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage	Within 1 year after treatment start	Single cardiovascular event
Time to first occurrence of TIA	Within 1 year after treatment start	Single cardiovascular event
Time to first occurrence of IS	Within 1 year after treatment start	Single cardiovascular event
Time to first occurrence of MI	Within 1 year after treatment start	Single cardiovascular event
Incidence density in study population of IS	Within 1 year after treatment start
Incidence density in study population of TIA	Within 1 year after treatment start
Incidence density in study population of IH	Within 1 year after treatment start
Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage	Within 1 year after treatment start
Incidence density in study population of MI	Within 1 year after treatment start
Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI	Within 1 year after treatment start