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OpenTrials
Completed

NCT Number: NCT02485873

Real-Life Evidence on Stroke Prevention in SPAF

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

Completed

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Key information

Conditions

Atrial Fibrillation (Prevention of Stroke) Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

As prescribed by treating physicians

Vitamin K antagonists

Drug

As prescribed by treating physicians

Primary outcomes

  1. 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)

    Time frame: Within 1 year after treatment start

    Composite cardiovascular endpoint

Secondary outcomes

  1. Time to first occurrence of IS

    Time frame: Within 1 year after treatment start

    Single cardiovascular event

  2. Time to first occurrence of TIA

    Time frame: Within 1 year after treatment start

    Single cardiovascular event

  3. Time to first occurrence of IH

    Time frame: Within 1 year after treatment start

    Single cardiovascular event

  4. Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage

    Time frame: Within 1 year after treatment start

    Single cardiovascular event

  5. Time to first occurrence of MI

    Time frame: Within 1 year after treatment start

    Single cardiovascular event

  6. Incidence density in study population of IS

    Time frame: Within 1 year after treatment start

  7. Incidence density in study population of TIA

    Time frame: Within 1 year after treatment start

  8. Incidence density in study population of IH

    Time frame: Within 1 year after treatment start

  9. Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage

    Time frame: Within 1 year after treatment start

  10. Incidence density in study population of MI

    Time frame: Within 1 year after treatment start

  11. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen, LP

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2015
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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