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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03760874
Other study ID # 19062013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 13, 2013
Est. completion date January 1, 2023

Study information

Verified date June 2020
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date January 1, 2023
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

- Patients with atrial fibrillation

- Indication for oral anticoagulant treatment

Exclusion Criteria:

- Missing Informed Consent Form

- Missing Contact Informations for Follow up

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy University of Campania "Luigi Vanvitelli" Naples

Sponsors (2)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli" Monaldi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thromboembolic Events 1 year
Primary Bleeding Events 1 year
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