Influenza Vaccination and Oral Anticoagulant Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

1.Efficacy of IV in patients on OAT

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Influenza Vaccination and Oral Anticoagulant Therapy

Official Title ^ICMJE

Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Anticoagulants
Influenza Vaccines

Intervention ^ICMJE

Drug: Influenza vaccination

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00222638

Responsible Party

Study ID Numbers ^ICMJE

04 MICV AI 01

Study Sponsor ^ICMJE

University Of Perugia

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

University Of Perugia

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP