Atrial Fibrillation Clinical Trial
Official title:
Prospective Register Study to Record Safety and Efficacy of Oral Anticoagulants in Atrial Fibrillation Patients
| 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 |
| Verified date | June 2020 |
| Source | University of Campania "Luigi Vanvitelli" |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | University of Campania "Luigi Vanvitelli" | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| University of Campania "Luigi Vanvitelli" | Monaldi Hospital |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Thromboembolic Events | 1 year | ||
| Primary | Bleeding Events | 1 year |
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