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Influenza Vaccination and Oral Anticoagulant Therapy

NCT ID: NCT00222638

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anticoagulants Influenza Vaccines

Keywords

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Oral anticoagulants Influenza virus Influenza vaccine Pharmacological interference

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Influenza vaccination

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Of Perugia

OTHER

Sponsor Role lead

Principal Investigators

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Alfonso Iorio

Role: PRINCIPAL_INVESTIGATOR

University Of Perugia

Maria Vecchioli

Role: PRINCIPAL_INVESTIGATOR

Regional Sanitary Agency (ASL2-Perugia)

Anna Maria Iorio

Role: PRINCIPAL_INVESTIGATOR

Institute of Virology - University of Perugia

Locations

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University of Perugia

Perugia, Perugia, Italy

Site Status

Countries

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Italy

References

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Iorio A, Basileo M, Marcucci M, Guercini F, Camilloni B, Paccamiccio E, Vecchioli M, Iorio AM. Influenza vaccination and vitamin K antagonist treatment: a placebo-controlled, randomized, double-blind crossover study. Arch Intern Med. 2010 Apr 12;170(7):609-16. doi: 10.1001/archinternmed.2010.49.

Reference Type DERIVED
PMID: 20386004 (View on PubMed)

Other Identifiers

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04 MICV AI 01

Identifier Type: -

Identifier Source: org_study_id