Back to results

Influenza Vaccination and Oral Anticoagulant Therapy

Primary Purpose

Anticoagulants, Influenza Vaccines

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Influenza vaccination

About this trial

This is an interventional treatment trial for Anticoagulants focused on measuring Oral anticoagulants, Influenza virus, Influenza vaccine, Pharmacological interference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Perugia

Outcomes

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

Full Information

NCT ID

NCT00222638

First Posted

September 13, 2005

Last Updated

September 13, 2005

Sponsor

University Of Perugia

1. Study Identification

Unique Protocol Identification Number

NCT00222638

Brief Title

Influenza Vaccination and Oral Anticoagulant Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2005

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Of Perugia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anticoagulants, Influenza Vaccines

Keywords

Oral anticoagulants, Influenza virus, Influenza vaccine, Pharmacological interference

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Influenza vaccination

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

1.Efficacy of IV in patients on OAT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfonso Iorio

Organizational Affiliation

University Of Perugia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maria Vecchioli

Organizational Affiliation

Regional Sanitary Agency (ASL2-Perugia)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anna Maria Iorio

Organizational Affiliation

Institute of Virology - University of Perugia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Perugia

City

Perugia

ZIP/Postal Code

06100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

20386004

Citation

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.

Results Reference

derived

Learn more about this trial

Influenza Vaccination and Oral Anticoagulant Therapy

We'll reach out to this number within 24 hrs