Atrial Fibrillation Research Database

June 10, 2020 updated by: Vincenzo Russo, University of Campania "Luigi Vanvitelli"

Prospective Register Study to Record Safety and Efficacy of Oral Anticoagulants in Atrial Fibrillation Patients

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy
        • Recruiting
        • University of Campania "Luigi Vanvitelli"
        • Contact:
        • Principal Investigator:
          • Vincenzo Russo, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with atrial fibrillation in clinical practice

Description

Inclusion Criteria:

  • Patients with atrial fibrillation
  • Indication for oral anticoagulant treatment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non Vitamin K Oral Anticoagulant
Dabigatran, Rivaroxaban, Apixaban, Edoxaban
Vitamin K Oral Anticoagulant
Warfarin, Acenocoumarol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thromboembolic Events
Time Frame: 1 year
1 year
Bleeding Events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Collaborators

Monaldi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2013

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19062013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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