Influenza Vaccination and Oral Anticoagulant Therapy

University Of Perugia100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Anticoagulants Influenza Vaccines

Interventions

Influenza vaccinationDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Perugia

Perugia, Perugia, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

1.Efficacy of IV in patients on OAT

Data from ClinicalTrials.gov

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