Real-Life Evidence on Stroke Prevention in SPAF (RELIEF)

Bayer

Status: Completed

Conditions: Atrial Fibrillation (Prevention of Stroke)

Treatments: Drug: Vitamin K antagonists; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02485873

DBOX 2014/00799 (Other Identifier)

18073

Details and patient eligibility

About

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

Enrollment: 8,607 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

8,607 participants in 2 patient groups

Rivaroxaban

Description:

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

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Vitamin K antagonists (VKA)

Description:

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

Treatment:

Drug: Vitamin K antagonists