NCT03760874

Brief Summary

All patients with atrial fibrillation who are treated with vitamin-k antagonists (warfarin, phenprocoumon) or non vitamin K oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in real world settings will be recorded in this register. Within this register a characterization of patients and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 13, 2013

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

8.6 years

First QC Date

November 27, 2018

Last Update Submit

June 10, 2020

Conditions

Anticoagulants and Bleeding DisordersAtrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Thromboembolic Events

    1 year

  • Bleeding Events

    1 year

Study Arms (2)

Non Vitamin K Oral Anticoagulant

Dabigatran, Rivaroxaban, Apixaban, Edoxaban

Vitamin K Oral Anticoagulant

Warfarin, Acenocoumarol.

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with atrial fibrillation in clinical practice

You may qualify if:

  • Patients with atrial fibrillation
  • Indication for oral anticoagulant treatment

You may not qualify if:

  • Missing Informed Consent Form
  • Missing Contact Informations for Follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campania "Luigi Vanvitelli"

Naples, Italy

RECRUITING

Related Publications (1)

  • Russo V, Carbone A, Attena E, Rago A, Mazzone C, Proietti R, Parisi V, Scotti A, Nigro G, Golino P, D'Onofrio A. Clinical Benefit of Direct Oral Anticoagulants Versus Vitamin K Antagonists in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves. Clin Ther. 2019 Dec;41(12):2549-2557. doi: 10.1016/j.clinthera.2019.10.008. Epub 2019 Nov 14.

    PMID: 31735436DERIVED

MeSH Terms

Conditions

Hemostatic DisordersAtrial Fibrillation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assistant Professor

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 30, 2018

Study Start

June 13, 2013

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)