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Trial record 84 of 156 for:    warfarin AND Vitamin K

Atrial Fibrillation Research Database

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ClinicalTrials.gov Identifier: NCT03760874
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
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, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03760874


Locations
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Italy
University of Campania "Luigi Vanvitelli" Recruiting
Naples, Italy
Contact: Vincenzo Russo       vincenzo.russo@unicampania.it   
Principal Investigator: Vincenzo Russo, MD PhD         
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Monaldi Hospital

Additional Information:

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Responsible Party: Vincenzo Russo, MD, PhD, Assistant Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03760874     History of Changes
Other Study ID Numbers: 19062013
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
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
Anticoagulants