NCT02485873

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

May 28, 2015

Last Update Submit

November 10, 2015

Conditions

Atrial Fibrillation (Prevention of Stroke)

Keywords

Non-valvular atrial fibrillation (NVAF)PeventionStroke

Outcome Measures

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)

    Composite cardiovascular endpoint

    Within 1 year after treatment start

Secondary Outcomes (11)

  • Time to first occurrence of IS

    Within 1 year after treatment start

  • Time to first occurrence of TIA

    Within 1 year after treatment start

  • Time to first occurrence of IH

    Within 1 year after treatment start

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

    Within 1 year after treatment start

  • Time to first occurrence of MI

    Within 1 year after treatment start

  • +6 more secondary outcomes

Study Arms (2)

Rivaroxaban

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

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Vitamin K antagonists (VKA)

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

Drug: Vitamin K antagonists

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

As prescribed by treating physicians

Rivaroxaban
Vitamin K antagonistsDRUG

As prescribed by treating physicians

Vitamin K antagonists (VKA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-valvular atrial fibrillation (NVAF)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Atrial FibrillationStroke

Interventions

Rivaroxabanacarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 30, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

DE(1)