Atrial Fibrillation Research Database

NCT ID: NCT03760874

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-13

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anticoagulants and Bleeding Disorders Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non Vitamin K Oral Anticoagulant

Dabigatran, Rivaroxaban, Apixaban, Edoxaban

No interventions assigned to this group

Vitamin K Oral Anticoagulant

Warfarin, Acenocoumarol.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with atrial fibrillation
* Indication for oral anticoagulant treatment

Exclusion Criteria

* Missing Informed Consent Form
* Missing Contact Informations for Follow up
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Monaldi Hospital

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Russo

MD, PhD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Vincenzo Russo

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31735436 (View on PubMed)

Other Identifiers

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19062013

Identifier Type: -

Identifier Source: org_study_id

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