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Atrial Fibrillation Research Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03760874
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : June 11, 2020
Monaldi Hospital
Information provided by (Responsible Party):
Vincenzo Russo, University of Campania "Luigi Vanvitelli"

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.

Condition or disease
Anticoagulants and Bleeding Disorders Atrial Fibrillation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Register Study to Record Safety and Efficacy of Oral Anticoagulants in Atrial Fibrillation Patients
Actual Study Start Date : June 13, 2013
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Thromboembolic Events [ Time Frame: 1 year ]
  2. Bleeding Events [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with atrial fibrillation in clinical practice

Inclusion Criteria:

  • Patients with atrial fibrillation
  • Indication for oral anticoagulant treatment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03760874

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University of Campania "Luigi Vanvitelli" Recruiting
Naples, Italy
Contact: Vincenzo Russo   
Principal Investigator: Vincenzo Russo, MD PhD         
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Monaldi Hospital
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vincenzo Russo, MD, PhD, Assistant Professor, University of Campania "Luigi Vanvitelli" Identifier: NCT03760874    
Other Study ID Numbers: 19062013
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Hemostatic Disorders
Blood Coagulation Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders