Influenza Vaccination and Oral Anticoagulant Therapy - Full Text View

Sponsor:	University Of Perugia
Information provided by:	University Of Perugia
ClinicalTrials.gov Identifier:	NCT00222638

Purpose

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

Condition	Intervention	Phase
Anticoagulants Influenza Vaccines	Drug: Influenza vaccination	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Flu

U.S. FDA Resources

Further study details as provided by University Of Perugia:

Primary Outcome Measures:

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

Secondary Outcome Measures:

1.Efficacy of IV in patients on OAT

Estimated Enrollment:	100
Study Start Date:	October 2004
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222638

Locations

Italy
University of Perugia
Perugia, Italy, 06100

Sponsors and Collaborators

University Of Perugia

Investigators

Principal Investigator:	Alfonso Iorio	University Of Perugia
Principal Investigator:	Maria Vecchioli	Regional Sanitary Agency (ASL2-Perugia)
Principal Investigator:	Anna Maria Iorio	Institute of Virology - University of Perugia

More Information

No publications provided by University Of Perugia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00222638 History of Changes
Other Study ID Numbers:	04 MICV AI 01
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
Health Authority:	Italy: Ministry of Health

Keywords provided by University Of Perugia:

Oral anticoagulants
Influenza virus
Influenza vaccine
Pharmacological interference

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012