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NCT00222638 Clinical Trial

Influenza Vaccination and Oral Anticoagulant Therapy

Anticoagulants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00222638
Other study ID # 04 MICV AI 01
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated September 13, 2005
Start date October 2004
Est. completion date May 2005

Study information
Verified date June 2005
Source University Of Perugia
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Influenza vaccination

Locations
Country Name City State
Italy University of Perugia Perugia

Sponsors (1)
Lead Sponsor Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1.Variations in INR value and in OAT weekly dosage after IV
Secondary 1.Efficacy of IV in patients on OAT
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