Influenza Vaccination and Oral Anticoagulant Therapy

Phase 4

Completed

• Conditions: Anticoagulants; Influenza Vaccines

• Registration Number: NCT00222638
• Lead Sponsor: University Of Perugia

Brief Summary

The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination

Detailed Description

The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-05
• Status Verified: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• OA Treatment
• Stable anticoagulation (previous two controls in range)
• Presence of indication for Influenza Vaccination
• Life expectancy > 6 months
• Signed Informed consent

Exclusion Criteria

• Absence of stable anticoagulation
• Absence of indication for Influenza Vaccination
• Life expectancy < 6 months
• Denied Informed Consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
1.Variations in INR value and in OAT weekly dosage after IV

Secondary Outcome Measures

Name	Time	Method
1.Efficacy of IV in patients on OAT

Trial Locations

Locations (1)

University of Perugia; 🇮🇹 Perugia, Italy