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

REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation (Prevention of Stroke)
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Vitamin K antagonists

• Study Type: Observational
• Enrollment (Actual): 8607

Contacts and Locations

Study Locations

• Germany
  • Many Locations, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation (NVAF)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban; Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention	Drug: Rivaroxaban (Xarelto, BAY59-7939); As prescribed by treating physicians
Vitamin K antagonists (VKA); NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention	Drug: Vitamin K antagonists; As prescribed by treating physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 1 year after treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first occurrence of IS	Single cardiovascular event	Within 1 year after treatment start
Time to first occurrence of TIA	Single cardiovascular event	Within 1 year after treatment start
Time to first occurrence of IH	Single cardiovascular event	Within 1 year after treatment start
Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage	Single cardiovascular event	Within 1 year after treatment start
Time to first occurrence of MI	Single cardiovascular event	Within 1 year after treatment start
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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen, LP

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (ESTIMATE): June 30, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Stroke; Non-valvular atrial fibrillation (NVAF); Pevention
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrin Modulating Agents; Protease Inhibitors; Micronutrients; Vitamins; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Rivaroxaban
• Other Study ID Numbers: 18073; DBOX 2014/00799 (OTHER: Company internal)