NCT02090543

Brief Summary

According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

February 12, 2014

Last Update Submit

January 20, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation

    Attributes and values in relation to the DCE-Choice-Set. The patient will receive a "test card" with the following attributes: bridging of anticoagulation, regular anticoagulation control, limitations to eating behaviour and alcohol consumption, once vs. twice daily intake of medication, neutral comparator for quantification display of preference: distance to therapy practice

    Within 1-4 weeks after patient enrollement

  • Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire

    At study entry

Study Arms (2)

Group 1

300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)

Drug: Phenprocoumon (Marcumar)

Group 2

300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)

Drug: Rivaroxaban (Xarelto, BAY-59 7939)

Interventions

Phenprocoumon (Marcumar)DRUG

common use, no requirements (real life situation)

Group 1
Rivaroxaban (Xarelto, BAY-59 7939)DRUG

common use, no requirements (real life situation)

Group 2

Eligibility Criteria

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

Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs

You may qualify if:

  • A.General Criteria (Group 1and Group2):
  • diagnosed non-valvular AF
  • older than 18 years
  • general capability and willingness to perform a structured patient interview in German
  • no participation in any other clinical or observational study over the last 3 month
  • Additional criteria for Group1 (VKA-experienced):
  • active VKA-therapy for at least 3 month without significant interruptions
  • in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.
  • Additional criteria for Group2 (rivaroxaban-experienced patients):
  • active rivaroxaban-therapy for at least 3 month without significant interruptions
  • in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.

You may not qualify if:

  • participation in any other clinical or observational study over the last 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

PhenprocoumonRivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 12, 2014

First Posted

March 18, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

DE(1)